SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00004031

Recruitment Status : Completed

First Posted : January 27, 2003

Results First Posted : February 2, 2021

Last Update Posted : February 2, 2021

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Sponsor:

Collaborators:

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

NCIC Clinical Trials Group

Information provided by (Responsible Party):

SWOG Cancer Research Network

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Lymphoma
Interventions	Biological: rituximab Drug: CHOP regimen Drug: carmustine Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy
Enrollment	397

Participant Flow

Recruitment Details
Pre-assignment Details	397 participants were registered, of whom 27 were ineligible. Of the 370 eligible participants, 117 were excluded from randomization and so only 253 underwent randomization.


Arm/Group Title	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Arm/Group Description	Cyclophosphamide 750 mg/m2 IV Day 1...	Cyclophosphamide 750 mg/m2 IV Day 1...
Arm/Group Description	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles rituximab: 375 mg/m2 IV every 21 days CHOP regimen cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate bone marrow ablation with stem cell support	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant. rituximab: 375 mg/m2 IV every 21 days CHOP regimen carmustine cyclophosphamide doxorubicin hydrochloride etoposide prednisone vincristine sulfate bone marrow ablation with stem cell support peripheral blood stem cell transplantation radiation therapy
Period Title: Overall Study
Started	128	125
Assessed for Adverse Events	123	113
Completed	103	104
Not Completed	25	21
Reason Not Completed
Adverse Event	5	0
Refusal unrelated to adverse events	2	11
Progression/relapse	9	4
Death	3	1
Other- not protocol specified	3	3
Reason under review	3	2

Baseline Characteristics

Arm/Group Title		CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant	Total
Arm/Group Description		Cyclophosphamide 750 mg/m2 IV Day 1...	Cyclophosphamide 750 mg/m2 IV Day 1...	Total of all reporting groups
Arm/Group Description		Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles rituximab: 375 mg/m2 IV every 21 days CHOP regimen cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate bone marrow ablation with stem cell support	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant. rituximab: 375 mg/m2 IV every 21 days CHOP regimen carmustine cyclophosphamide doxorubicin hydrochloride etoposide prednisone vincristine sulfate bone marrow ablation with stem cell support peripheral blood stem cell transplantation radiation therapy	Total of all reporting groups
Overall Number of Baseline Participants		128	125	253
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Eligible participants that were randomized to study arms.
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	128 participants	125 participants	253 participants
		51.3 (19.8 to 65.8)	49.6 (18.5 to 66.2)	50.6 (18.5 to 66.2)
Age, Customized Measure Type: Number Unit of measure: Percentage of participants
% >=60 years	Number Analyzed	128 participants	125 participants	253 participants
% >=60 years		18	20	19
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
	Female	56 43.8%	49 39.2%	105 41.5%
	Male	72 56.3%	76 60.8%	148 58.5%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
	Hispanic or Latino	2 1.6%	4 3.2%	6 2.4%
	Not Hispanic or Latino	113 88.3%	106 84.8%	219 86.6%
	Unknown or Not Reported	13 10.2%	15 12.0%	28 11.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
	American Indian or Alaska Native	0 0.0%	2 1.6%	2 0.8%
	Asian	3 2.3%	2 1.6%	5 2.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 0.8%	1 0.4%
	Black or African American	6 4.7%	7 5.6%	13 5.1%
	White	119 93.0%	109 87.2%	228 90.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	4 3.2%	4 1.6%
WHO B Cell Histology Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	128 participants	125 participants	253 participants
WHO B Cell Histology		114 89.1%	110 88.0%	224 88.5%
Diffuse Large B-Cell,Not Otherwise Specified		78 60.9%	86 68.8%	164 64.8%
WHO T Cell Histology Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	128 participants	125 participants	253 participants
WHO T Cell Histology		14 10.9%	15 12.0%	29 11.5%
Peripheral T, Not otherwise Specified		4 3.1%	6 4.8%	10 4.0%
Immunophenotyping Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	128 participants	125 participants	253 participants
B cell CHOP-R		76 59.4%	75 60.0%	151 59.7%
B cell CHOP		40 31.3%	35 28.0%	75 29.6%
Stage ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	128 participants	125 participants	253 participants
Bulky II		9 7.0%	4 3.2%	13 5.1%
III		3 2.3%	44 35.2%	47 18.6%
IV		78 60.9%	78 62.4%	156 61.7%
		[1] Measure Description: Staging based on the Ann Arbor staging criteria and on extent of disease at the time of diagnosis. Bulky disease determination made after surgical resection. Stage II: involvement of 2 or more lymph nodes on same side of diaphragm or localized involvement of an extralymphatic organ or site Stage III: lymph nodes on both sides of diaphragm which may be accompanied by localized involvement of an extralymphatic organ or site Stage IV: diffuse or disseminated involvement of one or more extralymphatic organs with/without associated lymph node or isolated extralymphatic organ involvement
Performance status >= 2 ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
		44 34.4%	48 38.4%	92 36.4%
		[1] Measure Description: Participants were graded according to the SWOG grading scale 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more that 50% of waking hours 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5: Dead
Elevated LDH ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
		104 81.3%	106 84.8%	210 83.0%
		[1] Measure Description: Serum LDH greater than institutional upper limit of normal
B Symptoms ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
		81 63.3%	75 60.0%	156 61.7%
		[1] Measure Description: Staging based on the Ann Arbor staging criteria B symptoms- fever, sweats, weight loss > 10% of body weight
International Prognostic Index: High ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
		44 34.4%	44 35.2%	88 34.8%
		[1] Measure Description: Number of risks factors (stage III or IV disease, serum LDH greater than normal, performance status of 2-4) participants have. High-Intermediate risk: 2 risk factors High risk: 3 risk factors
Extra nodal Sites >=2 Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
		29 22.7%	31 24.8%	60 23.7%
Bone marrow involvement- Yes ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	128 participants	125 participants	253 participants
		31 24.2%	19 15.2%	50 19.8%
		[1] Measure Description: Presence of lymphoma in the bone marrow based off of bone marrow biopsy done within 42 days prior to the first cycle of therapy

Outcome Measures

1.Primary Outcome


Title	2-year Overall Survival Rates
Description	Percentage of participants surviving 2 years post registration
Description	Percentage of participants surviving 2 years post registration
Time Frame	up to 2 years post registration

Outcome Measure Data

Analysis Population Description

Eligible participants that were randomized to study arms.


Arm/Group Title	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Arm/Group Description:	Cyclophosphamide 750 mg/m2 IV Day 1...	Cyclophosphamide 750 mg/m2 IV Day 1...
Arm/Group Description:	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles rituximab: 375 mg/m2 IV every 21 days CHOP regimen cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate bone marrow ablation with stem cell support	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant. rituximab: 375 mg/m2 IV every 21 days CHOP regimen carmustine cyclophosphamide doxorubicin hydrochloride etoposide prednisone vincristine sulfate bone marrow ablation with stem cell support peripheral blood stem cell transplantation radiation therapy
Overall Number of Participants Analyzed	128	125
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	71.1 (63.2 to 78.9)	73.7 (66.0 to 81.4)

2.Primary Outcome


Title	2 Year Progression-free Survival
Description	Percentage of participants without disease progression up to 2 years p...
Description	Percentage of participants without disease progression up to 2 years post-registration.
Time Frame	From registration until death

Outcome Measure Data

Analysis Population Description

Eligible participants that were randomized to study arms.


Arm/Group Title	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Arm/Group Description:	Cyclophosphamide 750 mg/m2 IV Day 1...	Cyclophosphamide 750 mg/m2 IV Day 1...
Arm/Group Description:	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles rituximab: 375 mg/m2 IV every 21 days CHOP regimen cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate bone marrow ablation with stem cell support	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant. rituximab: 375 mg/m2 IV every 21 days CHOP regimen carmustine cyclophosphamide doxorubicin hydrochloride etoposide prednisone vincristine sulfate bone marrow ablation with stem cell support peripheral blood stem cell transplantation radiation therapy
Overall Number of Participants Analyzed	128	125
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	55.4 (46.9 to 64.1)	69.1 (61.0 to 77.1)

3.Secondary Outcome


Title	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Description	Adverse Events (AEs) are reported by CTCAE Version 2.0. Only adverse e...
Description	Adverse Events (AEs) are reported by CTCAE Version 2.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Higher grades indicate higher severity of adverse events.
Time Frame	Duration of treatment and follow up until death or 3 years post registration

Outcome Measure Data

Analysis Population Description

Patients who received at least one dose of protocol treatment.


Arm/Group Title	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Arm/Group Description:	Cyclophosphamide 750 mg/m2 IV Day 1...	Cyclophosphamide 750 mg/m2 IV Day 1...
Arm/Group Description:	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cyclesXXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcyclophosphamideXXdoxorubicin hydrochlorideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell support	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.XXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcarmustineXXcyclophosphamideXXdoxorubicin hydrochlorideXXetoposideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell supportXXperipheral blood stem cell transplantationXXradiation therapy
Overall Number of Participants Analyzed	123	113
Measure Type: Number Unit of Measure: Participants
Abdominal pain/cramping	8	9
Alkaline phosphatase increase	9	15
Allergic reaction	0	8
Allergic rhinitis	4	5
Alopecia	43	36
Anemia	57	89
Anorexia	8	32
Anxiety/agitation	2	12
Apnea	0	1
Arthralgia	5	15
Arthritis	0	1
Ataxia (incoordination)	2	6
Bicarbonate decrease	0	1
Bilirubin increase	3	6
Blurred vision	0	4
Bone pain	6	4
Bruising	0	2
CO diffusion capacity decrease	0	2
Cardiac ischemia/infarction	0	1
Cardiovascular-other	0	4
Catheter related infection	1	11
Chest pain,not cardio or pleur	4	9
Colitis	0	2
Confusion	1	5
Conjunctivitis	0	1
Constipation/bowel obstruction	14	24
Cough	15	32
Creatinine increase	2	7
Cushingoid appearance	0	1
Dehydration	3	7
Delusions	0	1
Depression	3	12
Diarrhea without colostomy	13	49
Dizziness/light headedness	9	8
Dizziness/vertigo, NOS	1	1
Double vision	1	1
Dry skin	1	4
Dyspepsia/heartburn	6	10
Dyspnea	17	26
Dysuria	1	2
Ear-other	1	0
Earache	0	1
Edema	9	32
Endocrine-other	0	1
Epistaxis	0	4
Erectile impotence	0	2
Eryth/rash/eruption/desq, NOS	1	2
Erythema multiforme/blistering	0	1
Esophagitis/dysphagia	3	9
Eye-other	0	1
FEV1 decrease	0	3
Fatigue/malaise/lethargy	47	67
Febrile neutropenia	10	44
Fever without neutropenia	5	17
Fever, NOS	5	5
Flu-like symptoms-other	0	2
Flushing	1	18
Focal dermatitis	0	2
GGT increase	0	1
GI Mucositis, NOS	1	10
GI-other	0	2
GU-other	0	1
GVHD	0	3
Gastritis	0	2
Gynecomastia	1	0
Hallucinations	0	2
Hand-foot skin reaction	1	3
Headache	6	26
Hematuria	0	4
Hemorrhage-other	1	5
Hiccoughs	0	6
Hot flashes	3	3
Hyperglycemia	4	21
Hyperkalemia	0	1
Hypermagnesemia	0	1
Hypernatremia	0	2
Hypertension	0	5
Hyperuricemia	2	2
Hypoalbuminemia	1	10
Hypocalcemia	1	13
Hypoglycemia	0	1
Hypokalemia	2	10
Hypomagnesemia	0	6
Hyponatremia	2	9
Hypophosphatemia	0	9
Hypotension	1	15
Hypoxia	0	6
Infection w/o 3-4 neutropenia	4	13
Infection with 3-4 neutropenia	6	17
Infection, unk ANC	0	2
Inner ear-hearing loss	0	2
Insomnia	9	15
Invol. movement/restlessness	0	2
Joint,muscle,bone-other	4	0
Keratitis	0	1
LVEF decrease/CHF	2	3
Leukopenia	68	81
Liver-other	1	0
Local injection site reaction	1	0
Lung-other	1	2
Lymphedema	1	0
Lymphopenia	59	80
Melena/ GI bleeding	1	2
Memory loss	2	0
Menses changes	1	3
Metabolic-other	0	1
Mouth dryness	1	9
Muscle weakness (not neuro)	4	10
Myalgia	15	19
Myalgia/arthralgia, NOS	2	4
Nail changes	3	2
Nausea	31	66
Neuro-other	1	2
Neuropathic pain	1	1
Neutropenia/granulocytopenia	60	89
PRBC transfusion	3	32
Pain-other	15	17
Palpitations	0	2
Partial thromboplast time inc	1	5
Pericar. effusion/pericarditis	0	1
Personality/behavioral change	1	0
Petechiae/purpura	0	2
Phlebitis	3	0
Pigmentation changes/yellowing	3	3
Platelet transfusion	2	37
Pleural effusions	1	3
Pneumonitis/infiltrates	2	10
Proctitis	0	2
Proteinuria	0	1
Prothrombin time increase	1	3
Pruritus	3	7
Pulmonary edema	0	1
Pulmonary fibrosis	0	1
RT-GI mucositis, NOS	0	2
RT-esophagitis	0	1
RT-focal dermatitis, NOS	0	1
RT-pain	0	1
RT-pharyngeal dysphagia	0	2
Rash/desquamation	7	35
Rectal bleeding/hematochezia	0	2
Rectal/anal fistula	0	1
Rectal/perirectal pain	0	3
Renal failure	0	1
Reportable adverse event, NOS	1	0
Respiratory infect w/ neutrop	0	3
Respiratory infect w/o neutrop	4	3
Respiratory infection, unk ANC	0	1
Rigors/chills	2	15
SGOT (AST) increase	9	15
SGPT (ALT) increase	2	9
SIADH	0	1
Salivary gland changes	0	3
Second primary	1	0
Sense of smell	0	2
Sensory neuropathy	46	40
Sinus bradycardia	2	4
Sinus tachycardia	2	12
Skin-other	3	6
Somnolence/consciousness loss	0	2
Stomatitis/pharyngitis	12	57
Supraventricular arrhythmia	0	3
Surgery-wound infection	0	1
Sweating	9	11
Syncope	1	0
Syndrome-other	0	3
Taste disturbance	7	16
Thrombocytopenia	15	61
Thrombosis/embolism	3	3
Transplant-diarrhea	0	3
Transplant-granulocytopenia	0	5
Transplant-leukopenia	0	11
Transplant-pRBC transfusion	1	1
Transplant-plt transfusion	1	3
Transplant-rash/desquamation	0	3
Transplant-stomatitis/pharyng	0	1
Transplant-thrombocytopenia	0	13
Tremor	0	1
Urinary electrolyte wasting	0	1
Urinary frequency/urgency	1	3
Urinary retention	0	1
Urinary tr infect w/ neutrop	0	1
Urinary tr infect w/o neutrop	2	2
VOD associated weight gain	0	1
Vaginal bleeding	0	2
Vaginal dryness	0	1
Vaginitis	0	3
Vision,NOS	0	1
Voice change/stridor/larynx	0	1
Vomiting	15	40
Weakness (motor neuropathy)	13	4
Weight gain	7	8
Weight loss	2	11

Adverse Events

Time Frame	Duration of treatment and follow up until death or 3 years post registration
Adverse Event Reporting Description	Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.

Arm/Group Title	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Arm/Group Description	Cyclophosphamide 750 mg/m2 IV Day 1...	Cyclophosphamide 750 mg/m2 IV Day 1...
Arm/Group Description	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cyclesXXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcyclophosphamideXXdoxorubicin hydrochlorideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell support	Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.XXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcarmustineXXcyclophosphamideXXdoxorubicin hydrochlorideXXetoposideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell supportXXperipheral blood stem cell transplantationXXradiation therapy
All-Cause Mortality
	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
	Affected / at Risk (%)	Affected / at Risk (%)
Total	51/128 (39.84%)	39/125 (31.20%)
Serious Adverse Events Serious Adverse Events
	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/123 (3.25%)	4/113 (3.54%)
Cardiac disorders
LVEF decrease/CHF ^† 1	1/123 (0.81%)	0/113 (0.00%)
Gastrointestinal disorders
Stomatitis/pharyngitis ^† 1	0/123 (0.00%)	1/113 (0.88%)
General disorders
Reportable adverse event, NOS ^† 1	1/123 (0.81%)	0/113 (0.00%)
Syndrome-other ^† 1	0/123 (0.00%)	1/113 (0.88%)
Infections and infestations
Infection with 3-4 neutropenia ^† 1 [1]	1/123 (0.81%)	0/113 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary ^† 1	1/123 (0.81%)	0/113 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	0/123 (0.00%)	1/113 (0.88%)
Hypoxia ^† 1	0/123 (0.00%)	1/113 (0.88%)
Pneumonitis/infiltrates ^† 1	0/123 (0.00%)	2/113 (1.77%)
Pulmonary fibrosis ^† 1	0/123 (0.00%)	1/113 (0.88%)
1 Term from vocabulary, CTCAE (2.0) † Indicates events were collected by systematic assessment [1] Infection with grade 3-4 neutropenia [present or life-threatening sepsis (e.g., septic shock)]
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CHOP/CHOP-R x 3	CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
	Affected / at Risk (%)	Affected / at Risk (%)
Total	108/123 (87.80%)	106/113 (93.81%)
Blood and lymphatic system disorders
Anemia ^† 1	57/123 (46.34%)	89/113 (78.76%)
Febrile neutropenia ^† 1	10/123 (8.13%)	44/113 (38.94%)
PRBC transfusion ^† 1	3/123 (2.44%)	32/113 (28.32%)
Platelet transfusion ^† 1	2/123 (1.63%)	37/113 (32.74%)
Cardiac disorders
Sinus tachycardia ^† 1	2/123 (1.63%)	12/113 (10.62%)
Gastrointestinal disorders
Abdominal pain/cramping ^† 1	8/123 (6.50%)	9/113 (7.96%)
Constipation/bowel obstruction ^† 1	14/123 (11.38%)	24/113 (21.24%)
Diarrhea without colostomy ^† 1	13/123 (10.57%)	49/113 (43.36%)
Dyspepsia/heartburn ^† 1	6/123 (4.88%)	10/113 (8.85%)
Esophagitis/dysphagia ^† 1	3/123 (2.44%)	9/113 (7.96%)
GI Mucositis, NOS ^† 1	1/123 (0.81%)	10/113 (8.85%)
Mouth dryness ^† 1	1/123 (0.81%)	9/113 (7.96%)
Nausea ^† 1	31/123 (25.20%)	66/113 (58.41%)
Stomatitis/pharyngitis ^† 1	12/123 (9.76%)	56/113 (49.56%)
Vomiting ^† 1	15/123 (12.20%)	40/113 (35.40%)
General disorders
Edema ^† 1	9/123 (7.32%)	32/113 (28.32%)
Fatigue/malaise/lethargy ^† 1	47/123 (38.21%)	67/113 (59.29%)
Fever without neutropenia ^† 1	5/123 (4.07%)	17/113 (15.04%)
Pain-other ^† 1	15/123 (12.20%)	17/113 (15.04%)
Rigors/chills ^† 1	2/123 (1.63%)	15/113 (13.27%)
Sweating ^† 1	9/123 (7.32%)	11/113 (9.73%)
Immune system disorders
Allergic reaction ^† 1	0/123 (0.00%)	8/113 (7.08%)
Infections and infestations
Infection w/o 3-4 neutropenia ^† 1	4/123 (3.25%)	13/113 (11.50%)
Infection with 3-4 neutropenia ^† 1	5/123 (4.07%)	17/113 (15.04%)
Injury, poisoning and procedural complications
Catheter related infection ^† 1	1/123 (0.81%)	11/113 (9.73%)
Investigations
Alkaline phosphatase increase ^† 1	9/123 (7.32%)	15/113 (13.27%)
Bilirubin increase ^† 1	3/123 (2.44%)	6/113 (5.31%)
Creatinine increase ^† 1	2/123 (1.63%)	7/113 (6.19%)
Leukopenia ^† 1	68/123 (55.28%)	81/113 (71.68%)
Lymphopenia ^† 1	59/123 (47.97%)	80/113 (70.80%)
Neutropenia/granulocytopenia ^† 1	60/123 (48.78%)	89/113 (78.76%)
SGOT (AST) increase ^† 1	9/123 (7.32%)	15/113 (13.27%)
SGPT (ALT) increase ^† 1	2/123 (1.63%)	9/113 (7.96%)
Thrombocytopenia ^† 1	15/123 (12.20%)	61/113 (53.98%)
Transplant-leukopenia ^† 1	0/123 (0.00%)	11/113 (9.73%)
Transplant-thrombocytopenia ^† 1	0/123 (0.00%)	13/113 (11.50%)
Weight gain ^† 1	7/123 (5.69%)	8/113 (7.08%)
Weight loss ^† 1	2/123 (1.63%)	11/113 (9.73%)
Metabolism and nutrition disorders
Anorexia ^† 1	8/123 (6.50%)	32/113 (28.32%)
Dehydration ^† 1	3/123 (2.44%)	7/113 (6.19%)
Hyperglycemia ^† 1	4/123 (3.25%)	21/113 (18.58%)
Hypoalbuminemia ^† 1	1/123 (0.81%)	10/113 (8.85%)
Hypocalcemia ^† 1	1/123 (0.81%)	13/113 (11.50%)
Hypokalemia ^† 1	2/123 (1.63%)	10/113 (8.85%)
Hypomagnesemia ^† 1	0/123 (0.00%)	6/113 (5.31%)
Hyponatremia ^† 1	2/123 (1.63%)	9/113 (7.96%)
Hypophosphatemia ^† 1	0/123 (0.00%)	9/113 (7.96%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	5/123 (4.07%)	15/113 (13.27%)
Chest pain,not cardio or pleur ^† 1	4/123 (3.25%)	9/113 (7.96%)
Muscle weakness (not neuro) ^† 1	4/123 (3.25%)	10/113 (8.85%)
Myalgia ^† 1	15/123 (12.20%)	19/113 (16.81%)
Nervous system disorders
Ataxia (incoordination) ^† 1	2/123 (1.63%)	6/113 (5.31%)
Dizziness/light headedness ^† 1	9/123 (7.32%)	8/113 (7.08%)
Headache ^† 1	6/123 (4.88%)	26/113 (23.01%)
Sensory neuropathy ^† 1	46/123 (37.40%)	40/113 (35.40%)
Taste disturbance ^† 1	7/123 (5.69%)	16/113 (14.16%)
Weakness (motor neuropathy) ^† 1	13/123 (10.57%)	4/113 (3.54%)
Psychiatric disorders
Anxiety/agitation ^† 1	2/123 (1.63%)	12/113 (10.62%)
Depression ^† 1	3/123 (2.44%)	12/113 (10.62%)
Insomnia ^† 1	9/123 (7.32%)	15/113 (13.27%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	15/123 (12.20%)	32/113 (28.32%)
Dyspnea ^† 1	17/123 (13.82%)	26/113 (23.01%)
Hiccoughs ^† 1	0/123 (0.00%)	6/113 (5.31%)
Pneumonitis/infiltrates ^† 1	2/123 (1.63%)	8/113 (7.08%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	43/123 (34.96%)	36/113 (31.86%)
Pruritus ^† 1	3/123 (2.44%)	7/113 (6.19%)
Rash/desquamation ^† 1	7/123 (5.69%)	35/113 (30.97%)
Skin-other ^† 1	3/123 (2.44%)	6/113 (5.31%)
Vascular disorders
Flushing ^† 1	1/123 (0.81%)	18/113 (15.93%)
Hypotension ^† 1	1/123 (0.81%)	15/113 (13.27%)
1 Term from vocabulary, CTCAE (2.0) † 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:	Study Statistician
Organization:	SWOG Statistics and Data Management Center
Phone:	2066674623

Publications of Results:

Stiff PJ, Unger JM, Cook J, et al.: Randomized phase III U.S./Canadian intergroup trial (SWOG S9704) comparing CHOP ± R for eight cycles to CHOP ± R for six cycles followed by autotransplant for patients with high-intermediate (H-Int) or high IPI grade diffuse aggressive non-Hodgkin lymphoma (NHL). [Abstract] J Clin Oncol 29 (Suppl 15): A-8001, 2011.

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

Cook JR, Goldman B, Tubbs RR, Rimsza L, Leblanc M, Stiff P, Fisher R. Clinical significance of MYC expression and/or "high-grade" morphology in non-Burkitt, diffuse aggressive B-cell lymphomas: a SWOG S9704 correlative study. Am J Surg Pathol. 2014 Apr;38(4):494-501. doi: 10.1097/PAS.0000000000000147.

Stiff PJ, Unger JM, Cook JR, Constine LS, Couban S, Stewart DA, Shea TC, Porcu P, Winter JN, Kahl BS, Miller TP, Tubbs RR, Marcellus D, Friedberg JW, Barton KP, Mills GM, LeBlanc M, Rimsza LM, Forman SJ, Fisher RI. Autologous transplantation as consolidation for aggressive non-Hodgkin's lymphoma. N Engl J Med. 2013 Oct 31;369(18):1681-90. doi: 10.1056/NEJMoa1301077.

Layout table for additonal information

Responsible Party:	SWOG Cancer Research Network
ClinicalTrials.gov Identifier:	NCT00004031
Other Study ID Numbers:	CDR0000065658 S9704 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted:	December 10, 1999
First Posted:	January 27, 2003
Results First Submitted:	November 18, 2020
Results First Posted:	February 2, 2021
Last Update Posted:	February 2, 2021

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