Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) (CATNON)

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ClinicalTrials.gov Identifier: NCT00626990

Recruitment Status : Active, not recruiting

First Posted : February 29, 2008

Results First Posted : September 11, 2023

Last Update Posted : September 11, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

NCIC Clinical Trials Group

Radiation Therapy Oncology Group

Medical Research Council

Merck Sharp & Dohme LLC

Information provided by (Responsible Party):

European Organisation for Research and Treatment of Cancer - EORTC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Brain and Central Nervous System Tumors
Interventions	Drug: temozolomide Genetic: DNA methylation analysis Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy
Enrollment	751

Participant Flow

Recruitment Details	After registration step was completed, eligible patients were randomized into the trial within 8 days from the start of radiotherapy; at this time, all baseline requirements for the study had to be fulfilled.
Pre-assignment Details	The patients were first registered to the trial by authorized sites. For all patients, tumor and blood samples had to be sent for histology review, 1p/19q analysis and O6-Methylguanine-DNA Methyltransferase (MGMT) assay. If inclusion was based on central pathology and 1p/19q diagnosis the patient could be randomized into the trial once found eligible at central assessment.


Arm/Group Title	RT Alone	RT & Concurrent CT	RT + Adjuvant CT	RT & Concurrent CT + Adjuvant CT
Arm/Group Description	radiation therapy alone ...	Radiotherapy and concurrent temozol...	Radiotherapy plus adjuvant temozolo...	Radiotherapy and concurrent chemoth...
Arm/Group Description	radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
Period Title: Overall Study
Started	189	188	186	188
Completed	175	163	109	93
Not Completed	14	25	77	95
Reason Not Completed
Lack of Efficacy	6	7	49	40
Adverse Event	1	7	14	28
Death	0	1	0	0
Withdrawal by Subject	3	1	5	11
Protocol Violation	0	1	1	0
Various different reasons/missing	4	8	8	16

Baseline Characteristics

Arm/Group Title		RT Alone	RT & Concurrent CT	RT + Adjuvant CT	RT & Concurrent CT + Adjuvant CT	Total
Arm/Group Description		radiation therapy alone ...	Radiotherapy and concurrent temozol...	Radiotherapy plus adjuvant temozolo...	Radiotherapy and concurrent chemoth...	Total of all reporting groups
Arm/Group Description		radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Total of all reporting groups
Overall Number of Baseline Participants		189	188	186	188	751
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	174 92.1%	168 89.4%	174 93.5%	180 95.7%	696 92.7%
	>=65 years	15 7.9%	20 10.6%	12 6.5%	8 4.3%	55 7.3%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
		42 (19 to 81.2)	43.1 (20.1 to 77.1)	40 (20 to 82.3)	42.8 (18.3 to 80.1)	42.2 (18.3 to 82.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	Female	75 39.7%	68 36.2%	82 44.1%	82 43.6%	307 40.9%
	Male	114 60.3%	120 63.8%	104 55.9%	106 56.4%	444 59.1%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants
						0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Number Unit of measure: Participants
Canada	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Canada		6	5	6	6	23
Netherlands	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Netherlands		19	20	19	14	72
Belgium	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Belgium		19	20	16	18	73
United States	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
United States		30	22	21	28	101
Italy	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Italy		13	10	16	11	50
United Kingdom	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
United Kingdom		31	39	39	34	143
Australia	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Australia		14	22	21	25	82
France	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
France		26	23	22	22	93
Switzerland	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Switzerland		5	7	7	7	26
Germany	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Germany		22	13	17	18	70
Spain	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Spain		4	6	1	3	14
Turkey	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
Turkey		0	1	1	2	4
Presence of oligodendroglial elements Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	No	146 77.2%	144 76.6%	143 76.9%	144 76.6%	577 76.8%
	Yes	43 22.8%	44 23.4%	43 23.1%	44 23.4%	174 23.2%
World Health Organization (WHO) Performance Status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	ECOG performance status 0 (good prognosis)	111 58.7%	110 58.5%	108 58.1%	112 59.6%	441 58.7%
	ECOG performance status >0 (poorer prognosis)	78 41.3%	78 41.5%	78 41.9%	76 40.4%	310 41.3%
Procedure for pathology and genetic testing Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	by local site laboratory assessment	70 37.0%	70 37.2%	68 36.6%	54 28.7%	262 34.9%
	by central laboratory assessment	119 63.0%	118 62.8%	116 62.4%	134 71.3%	487 64.8%
	Unknown	0 0.0%	0 0.0%	2 1.1%	0 0.0%	2 0.3%
Presence of 1p LOH Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	No loss	175 92.6%	176 93.6%	172 92.5%	175 93.1%	698 92.9%
	Loss	14 7.4%	12 6.4%	14 7.5%	13 6.9%	53 7.1%
MGMT Methylation status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	189 participants	188 participants	186 participants	188 participants	751 participants
	Methylated	62 32.8%	55 29.3%	66 35.5%	56 29.8%	239 31.8%
	Unmethylated	83 43.9%	79 42.0%	78 41.9%	87 46.3%	327 43.5%
	Undetermined/invalid	44 23.3%	54 28.7%	42 22.6%	45 23.9%	185 24.6%

Outcome Measures

1.Primary Outcome


Title	Overall Survival as Measured From the Day of Randomization
Description	The duration of survival is the time interval between randomization an...
Description	The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
Time Frame	from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)

Outcome Measure Data

Analysis Population Description

This trial studied 2 questions 1) effect of concomitant Temozolomide (TMZ) 2) effect of adjuvant TMZ. The 4 randomized arms were combined. Absence of concomitant TMZ including Arm Radiotherapy (RT) alone & Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT & Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone & Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ & Arm TMZ/RT followed by adjuvant TMZ


Arm/Group Title	Absence of Concomitant Temozolomide (TMZ)	Presence of Concomitant Temozolomide (TMZ)	Absence of Adjuvant Temozolomide (TMZ)	Presence of Adjuvant Temozolomide (TMZ)
Arm/Group Description:	Including 2 randomized arms: Arm RT...	Including 2 randomized arms: Arm TM...	Including two randomized arms: Arm ...	Including to 2 randomized arms: Arm...
Arm/Group Description:	Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ	Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ	Including two randomized arms: Arm RT alone and Arm TMZ/RT	Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
Overall Number of Participants Analyzed	375	376	377	374
Median (95% Confidence Interval) Unit of Measure: Months
	60.42 (45.7 to 71.49)	66.92 (48.53 to 82.33)	46.92 (37.88 to 56.94)	82.33 (67.19 to 116.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Absence of Concomitant Temozolomide (TMZ), Presence of Concomitant Temozolomide (TMZ)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.76
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 99.1% 0.73 to 1.28
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Absence of Adjuvant Temozolomide (TMZ), Presence of Adjuvant Temozolomide (TMZ)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95% 0.52 to 0.79
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-free Survival
Description	Disease progression is defined as radiological or neurological/clinica...
Description	Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.
Time Frame	from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)

Outcome Measure Data

Analysis Population Description

This trial studied separately two questions 1) effect of concomitant TMZ 2) effect of adjuvant TMZ. The 4 randomized arms were combined before analysis. Absence of concomitant TMZ including Arm RT alone & Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT & Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone & Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ & Arm TMZ/RT followed by adjuvant TMZ


Arm/Group Title	Absence of Concomitant TMZ	Presence of Concomitant TMZ	Absence of Adjuvant TMZ	Presence of Adjuvant TMZ
Arm/Group Description:	Including 2 randomized arms: Arm RT...	Including 2 randomized arms: Arm TM...	Including two randomized arms: Arm ...	Including to 2 randomized arms: Arm...
Arm/Group Description:	Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ	Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ	Including two randomized arms: Arm RT alone and Arm TMZ/RT	Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
Overall Number of Participants Analyzed	375	376	377	374
Median (95% Confidence Interval) Unit of Measure: Months
	20.9 (17.25 to 26.64)	33.02 (23.82 to 46.06)	19.09 (14.59 to 23.82)	42.81 (27.83 to 56.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Absence of Concomitant TMZ, Presence of Concomitant TMZ
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.11
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95% 0.72 to 1.03
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Absence of Adjuvant TMZ, Presence of Adjuvant TMZ
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95% 0.49 to 0.70
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Quality of Life of the Patient
Description	Quality of life was assessed by the EORTC Quality of Life Questionnair...
Description	Quality of life was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20
Time Frame	from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	Neurological Deterioration Free Survival
Description	Neurological deterioration is defined as a decrease in WHO performance...
Description	Neurological deterioration is defined as a decrease in WHO performance status as follows: decrease in WHO performance status for patients with baseline WHO performance status 0: deterioration to WHO performance status 2 or worse for which no other explanation is present, and which is maintained for at least three months for patients with baseline WHO performance status 1 or 2: deterioration to WHO performance status 3 or worse for which no other explanation is present and which is maintained for at least three months The date of neurological deterioration will be the first date the persistent decrease in performance status was diagnosed. Neurological deterioration free progression is the time interval between the date of randomization and the date of neurological deterioration or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination
Time Frame	within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Adverse Event Reporting Description	Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments

Arm/Group Title	RT Alone	RT & Concurrent CT	RT + Adjuvant CT	RT & Concurrent CT + Adjuvant CT
Arm/Group Description	radiation therapy alone ...	Radiotherapy and concurrent temozol...	Radiotherapy plus adjuvant temozolo...	Radiotherapy and concurrent chemoth...
Arm/Group Description	radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
All-Cause Mortality
	RT Alone	RT & Concurrent CT	RT + Adjuvant CT	RT & Concurrent CT + Adjuvant CT
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	107/189 (56.61%)	97/188 (51.60%)	78/186 (41.94%)	74/188 (39.36%)
Serious Adverse Events Serious Adverse Events
	RT Alone	RT & Concurrent CT	RT + Adjuvant CT	RT & Concurrent CT + Adjuvant CT
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	13/186 (6.99%)	27/185 (14.59%)	32/183 (17.49%)	32/185 (17.30%)
Blood and lymphatic system disorders
BLOOD ^† 1	2/186 (1.08%)	2/185 (1.08%)	2/183 (1.09%)	5/185 (2.70%)
LYMPHATICS ^† 1	2/186 (1.08%)	0/185 (0.00%)	1/183 (0.55%)	0/185 (0.00%)
Cardiac disorders
CARDIAC(GENERAL) ^† 1	1/186 (0.54%)	0/185 (0.00%)	0/183 (0.00%)	1/185 (0.54%)
Eye disorders
OCULAR/VISUAL ^† 1	0/186 (0.00%)	2/185 (1.08%)	0/183 (0.00%)	1/185 (0.54%)
Gastrointestinal disorders
GASTROINTESTINAL ^† 1	1/186 (0.54%)	2/185 (1.08%)	4/183 (2.19%)	5/185 (2.70%)
General disorders
CONSTITUTIONAL SYMPTOMS ^† 1	0/186 (0.00%)	7/185 (3.78%)	2/183 (1.09%)	2/185 (1.08%)
PAIN ^† 1	2/186 (1.08%)	2/185 (1.08%)	4/183 (2.19%)	3/185 (1.62%)
Immune system disorders
ALLERGY/IMMUNOLOGY ^† 1	0/186 (0.00%)	0/185 (0.00%)	2/183 (1.09%)	2/185 (1.08%)
Infections and infestations
INFECTION ^† 1	6/186 (3.23%)	4/185 (2.16%)	8/183 (4.37%)	6/185 (3.24%)
Metabolism and nutrition disorders
METABOLIC/LABORATORY ^† 1	1/186 (0.54%)	2/185 (1.08%)	1/183 (0.55%)	1/185 (0.54%)
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE ^† 1	0/186 (0.00%)	0/185 (0.00%)	1/183 (0.55%)	0/185 (0.00%)
Nervous system disorders
NEUROLOGY ^† 1	9/186 (4.84%)	15/185 (8.11%)	12/183 (6.56%)	10/185 (5.41%)
Renal and urinary disorders
RENAL/GENITOURINARY ^† 1	0/186 (0.00%)	0/185 (0.00%)	1/183 (0.55%)	1/185 (0.54%)
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY ^† 1	0/186 (0.00%)	0/185 (0.00%)	0/183 (0.00%)	1/185 (0.54%)
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN ^† 1	1/186 (0.54%)	2/185 (1.08%)	0/183 (0.00%)	2/185 (1.08%)
Vascular disorders
VASCULAR ^† 1	0/186 (0.00%)	1/185 (0.54%)	1/183 (0.55%)	0/185 (0.00%)
1 Term from vocabulary, CTCAE (3.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	RT Alone	RT & Concurrent CT	RT + Adjuvant CT	RT & Concurrent CT + Adjuvant CT
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	182/186 (97.85%)	183/185 (98.92%)	182/183 (99.45%)	185/185 (100.00%)
Blood and lymphatic system disorders
BLOOD ^† 1	5/186 (2.69%)	12/185 (6.49%)	10/183 (5.46%)	12/185 (6.49%)
LYMPHATICS ^† 1	12/186 (6.45%)	10/185 (5.41%)	14/183 (7.65%)	10/185 (5.41%)
Cardiac disorders
CARDIAC(GENERAL) ^† 1	9/186 (4.84%)	15/185 (8.11%)	17/183 (9.29%)	15/185 (8.11%)
Ear and labyrinth disorders
AUDITORY/EAR ^† 1	30/186 (16.13%)	23/185 (12.43%)	33/183 (18.03%)	23/185 (12.43%)
Endocrine disorders
ENDOCRINE ^† 1	6/186 (3.23%)	8/185 (4.32%)	9/183 (4.92%)	8/185 (4.32%)
Eye disorders
OCULAR/VISUAL ^† 1	51/186 (27.42%)	62/185 (33.51%)	48/183 (26.23%)	62/185 (33.51%)
Gastrointestinal disorders
GASTROINTESTINAL ^† 1	107/186 (57.53%)	136/185 (73.51%)	158/183 (86.34%)	136/185 (73.51%)
General disorders
CONSTITUTIONAL SYMPTOMS ^† 1	151/186 (81.18%)	160/185 (86.49%)	170/183 (92.90%)	160/185 (86.49%)
PAIN ^† 1	129/186 (69.35%)	131/185 (70.81%)	138/183 (75.41%)	131/185 (70.81%)
Hepatobiliary disorders
HEPATOBILIAR/PANCREAS ^† 1	0/186 (0.00%)	0/185 (0.00%)	0/183 (0.00%)	0/185 (0.00%)
Immune system disorders
ALLERGY/IMMUNOLOGY ^† 1	7/186 (3.76%)	9/185 (4.86%)	11/183 (6.01%)	9/185 (4.86%)
Infections and infestations
INFECTION ^† 1	37/186 (19.89%)	35/185 (18.92%)	72/183 (39.34%)	35/185 (18.92%)
Metabolism and nutrition disorders
METABOLIC/LABORATORY ^† 1	7/186 (3.76%)	7/185 (3.78%)	8/183 (4.37%)	7/185 (3.78%)
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE ^† 1	16/186 (8.60%)	17/185 (9.19%)	23/183 (12.57%)	17/185 (9.19%)
Nervous system disorders
NEUROLOGY ^† 1	147/186 (79.03%)	153/185 (82.70%)	148/183 (80.87%)	153/185 (82.70%)
Renal and urinary disorders
RENAL/GENITOURINARY ^† 1	11/186 (5.91%)	7/185 (3.78%)	16/183 (8.74%)	7/185 (3.78%)
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION ^† 1	2/186 (1.08%)	4/185 (2.16%)	7/183 (3.83%)	4/185 (2.16%)
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY ^† 1	8/186 (4.30%)	9/185 (4.86%)	17/183 (9.29%)	9/185 (4.86%)
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN ^† 1	146/186 (78.49%)	139/185 (75.14%)	147/183 (80.33%)	139/185 (75.14%)
Surgical and medical procedures
SURGERY/INTRA-OPERATIVE INJURY ^† 1	0/186 (0.00%)	0/185 (0.00%)	0/183 (0.00%)	0/185 (0.00%)
Vascular disorders
VASCULAR ^† 1	2/186 (1.08%)	7/185 (3.78%)	5/183 (2.73%)	7/185 (3.78%)
1 Term from vocabulary, CTCAE (3.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Dr. Thierry Gorlia
Organization:	EORTC
Phone:	027741652
EMail:	thierry.gorlia@eortc.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tesileanu CMS, Sanson M, Wick W, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, van Linde ME, Aldape K, Jenkins RB, Kros JM, Wesseling P, von Deimling A, Hoogstrate Y, de Heer I, Atmodimedjo PN, Dubbink HJ, Brouwer RWW, van IJcken WFJ, Cheung KJ, Golfinopoulos V, Baumert BG, Gorlia T, French PJ, van den Bent MJ. Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial. Clin Cancer Res. 2022 Jun 13;28(12):2527-2535. doi: 10.1158/1078-0432.CCR-21-4283.

van den Bent MJ, Tesileanu CMS, Wick W, Sanson M, Brandes AA, Clement PM, Erridge S, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Caparrotti F, Lesimple T, Clenton S, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, de Heer I, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, French P, Baumert BG. Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2021 Jun;22(6):813-823. doi: 10.1016/S1470-2045(21)00090-5. Epub 2021 May 14.

van den Bent MJ, Baumert B, Erridge SC, Vogelbaum MA, Nowak AK, Sanson M, Brandes AA, Clement PM, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Brachman DG, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Weber DC, Lesimple T, Clenton S, Gijtenbeek A, Pascoe S, Herrlinger U, Hau P, Dhermain F, van Heuvel I, Stupp R, Aldape K, Jenkins RB, Dubbink HJ, Dinjens WNM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, Wick W, Kros JM. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8. Erratum In: Lancet. 2017 Oct 7;390(10103):1644.

Layout table for additonal information

Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT00626990
Other Study ID Numbers:	EORTC-26053-22054 NCIC CTG CEC.1 ( Other Identifier: NCI-C ) RTOG-0834 ( Other Identifier: RTOG ) 2006-001533-17 ( EudraCT Number ) P04839 ( Other Grant/Funding Number: Merck ) MRC BR14 ( Other Identifier: MRC CTU )
First Submitted:	February 28, 2008
First Posted:	February 29, 2008
Results First Submitted:	February 14, 2023
Results First Posted:	September 11, 2023
Last Update Posted:	September 11, 2023

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