Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy (S1115)

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ClinicalTrials.gov Identifier: NCT01658943

Recruitment Status : Completed

First Posted : August 7, 2012

Results First Posted : March 9, 2016

Last Update Posted : March 9, 2016

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Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Pancreatic Acinar Cell Carcinoma Pancreatic Ductal Adenocarcinoma Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer
Interventions	Drug: Akt Inhibitor MK2206 Drug: Fluorouracil Drug: Oxaliplatin Drug: Selumetinib
Enrollment	137

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	mFOLFOX	MK2206 and Selumetinib
Arm/Group Description	Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...
Arm/Group Description	Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started	70	67
Eligible	63	58
Eligible and Began Protocol Therapy	62	58
Completed	0	0
Not Completed	70	67
Reason Not Completed
Adverse Event	6	13
Withdrawal by Subject	9	2
Progression/Relapse	39	40
Death	4	2
not protocol specified	4	1
Not eligible	7	9
Withdrew prior to beginning protocol Tx	1	0

Baseline Characteristics

Arm/Group Title		mFOLFOX	MK2206 and Selumetinib	Total
Arm/Group Description		Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...	Total of all reporting groups
Arm/Group Description		Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Total of all reporting groups
Overall Number of Baseline Participants		62	58	120
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Eligible and analyzable patients.
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	62 participants	58 participants	120 participants
		65.6 (34.2 to 82.8)	69.4 (54.2 to 88.0)	67.3 (34.2 to 88.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	62 participants	58 participants	120 participants
	Female	40 64.5%	23 39.7%	63 52.5%
	Male	22 35.5%	35 60.3%	57 47.5%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	62 participants	58 participants	120 participants
	Hispanic or Latino	3 4.8%	1 1.7%	4 3.3%
	Not Hispanic or Latino	59 95.2%	57 98.3%	116 96.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	62 participants	58 participants	120 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	4 6.5%	4 6.9%	8 6.7%
	Native Hawaiian or Other Pacific Islander	1 1.6%	1 1.7%	2 1.7%
	Black or African American	7 11.3%	4 6.9%	11 9.2%
	White	50 80.6%	49 84.5%	99 82.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Prior Systemic Therapy Measure Type: Number Unit of measure: Participants	Number Analyzed	62 participants	58 participants	120 participants
4 months or less		23	22	45
more than 4 months		39	36	75
Liver Metastasis Measure Type: Number Unit of measure: Participants	Number Analyzed	62 participants	58 participants	120 participants
Yes		39	43	82
No		23	15	38

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	From date of registration to date of death due to any cause. Patients ...
Description	From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients.


Arm/Group Title	mFOLFOX	MK2206 and Selumetinib
Arm/Group Description:	Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...
Arm/Group Description:	Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	62	58
Median (95% Confidence Interval) Unit of Measure: months
	6.7 (6.0 to 8.3)	3.9 (3.5 to 4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mFOLFOX, MK2206 and Selumetinib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.15
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

2.Secondary Outcome


Title	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Description	Only adverse events that are possibly, probably or definitely related ...
Description	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Eligible patients who received any treatment and were assessed for adverse events are included in this summary.


Arm/Group Title	mFOLFOX	MK2206 and Selumetinib
Arm/Group Description:	Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...
Arm/Group Description:	Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	62	57
Measure Type: Number Unit of Measure: Participants
Abdominal pain	1	0
Alanine aminotransferase increased	0	4
Alkaline phosphatase increased	0	2
Anemia	2	3
Anorexia	1	1
Aspartate aminotransferase increased	0	3
Blood bilirubin increased	1	0
Cognitive disturbance	0	1
Dehydration	1	6
Device related infection	1	0
Diarrhea	4	4
Edema face	0	1
Encephalopathy	0	1
Erythema multiforme	0	1
Erythroderma	0	1
Fatigue	8	7
Generalized muscle weakness	0	1
Hepatic failure	0	1
Hyperglycemia	1	7
Hypertension	2	5
Hypokalemia	1	1
Hypomagnesemia	1	0
Hyponatremia	1	4
Hypophosphatemia	0	1
Hypotension	1	1
Hypoxia	0	1
Left ventricular systolic dysfunction	0	1
Lung infection	1	1
Lymphocyte count decreased	8	0
Mucositis oral	1	4
Multi-organ failure	0	1
Nausea	3	0
Neoplasms benign, malignant and unspecified	0	2
Neutrophil count decreased	4	0
Platelet count decreased	1	0
Rash acneiform	0	5
Rash maculo-papular	0	7
Skin infection	0	1
Soft tissue infection	0	1
Stevens-Johnson syndrome	0	1
Syncope	0	1
Vomiting	3	1
Weight loss	1	0
White blood cell decreased	2	0

3.Other Pre-specified Outcome


Title	Progression-free Survival
Description	From date of registration to date of first documentation of progressio...
Description	From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients.


Arm/Group Title	mFOLFOX	MK2206 and Selumetinib
Arm/Group Description:	Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...
Arm/Group Description:	Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	62	58
Median (95% Confidence Interval) Unit of Measure: months
	2.0 (1.8 to 2.9)	1.9 (1.8 to 2.1)

4.Other Pre-specified Outcome


Title	Objective Response Rate
Description	Confirmed response (CR) is two or more objective statuses of CR a mini...
Description	Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All eligible and analyzable patients with measurable disease.


Arm/Group Title	mFOLFOX	MK2206 and Selumetinib
Arm/Group Description:	Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...
Arm/Group Description:	Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	57	55
Measure Type: Number Unit of Measure: participants
Partial Response	4	0
Unconfirmed Partial Response	1	1
Stable/No response	14	12
Increasing disease	29	34
Symptomatic Deterioration	3	2
Assessment Inadequate	6	6

Adverse Events

Time Frame	Up to 3 years
Adverse Event Reporting Description	Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.

Arm/Group Title	mFOLFOX	MK2206 and Selumetinib
Arm/Group Description	Patients receive 85 mg/m^2 oxalipla...	Patients receive 135 mg MK2206 PO o...
Arm/Group Description	Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
	mFOLFOX	MK2206 and Selumetinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	mFOLFOX	MK2206 and Selumetinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/62 (3.23%)	37/57 (64.91%)
Blood and lymphatic system disorders
Anemia ^†	0/62 (0.00%)	2/57 (3.51%)
Cardiac disorders
Left ventricular systolic dysfunction ^†	0/62 (0.00%)	1/57 (1.75%)
Myocardial infarction ^†	0/62 (0.00%)	1/57 (1.75%)
Gastrointestinal disorders
Abdominal distension ^†	0/62 (0.00%)	1/57 (1.75%)
Abdominal pain ^†	0/62 (0.00%)	1/57 (1.75%)
Colonic perforation ^†	1/62 (1.61%)	0/57 (0.00%)
Constipation ^†	0/62 (0.00%)	2/57 (3.51%)
Diarrhea ^†	0/62 (0.00%)	3/57 (5.26%)
Duodenal perforation ^†	0/62 (0.00%)	1/57 (1.75%)
Dysphagia ^†	0/62 (0.00%)	1/57 (1.75%)
Gastric perforation ^†	0/62 (0.00%)	1/57 (1.75%)
Mucositis oral ^†	0/62 (0.00%)	2/57 (3.51%)
Nausea ^†	0/62 (0.00%)	1/57 (1.75%)
Vomiting ^†	0/62 (0.00%)	2/57 (3.51%)
General disorders
Fatigue ^†	0/62 (0.00%)	2/57 (3.51%)
Fever ^†	0/62 (0.00%)	2/57 (3.51%)
General disorders and admin site conditions - Other ^†	0/62 (0.00%)	1/57 (1.75%)
Multi-organ failure ^†	0/62 (0.00%)	1/57 (1.75%)
Hepatobiliary disorders
Hepatic failure ^†	0/62 (0.00%)	1/57 (1.75%)
Infections and infestations
Infections and infestations-Other ^†	0/62 (0.00%)	2/57 (3.51%)
Lung infection ^†	1/62 (1.61%)	1/57 (1.75%)
Sepsis ^†	1/62 (1.61%)	2/57 (3.51%)
Skin infection ^†	0/62 (0.00%)	1/57 (1.75%)
Soft tissue infection ^†	0/62 (0.00%)	1/57 (1.75%)
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury ^†	0/62 (0.00%)	1/57 (1.75%)
Spinal fracture ^†	0/62 (0.00%)	1/57 (1.75%)
Investigations
Alanine aminotransferase increased ^†	0/62 (0.00%)	1/57 (1.75%)
Alkaline phosphatase increased ^†	0/62 (0.00%)	2/57 (3.51%)
Aspartate aminotransferase increased ^†	0/62 (0.00%)	1/57 (1.75%)
Blood bilirubin increased ^†	0/62 (0.00%)	2/57 (3.51%)
Investigations-Other ^†	0/62 (0.00%)	1/57 (1.75%)
Metabolism and nutrition disorders
Anorexia ^†	0/62 (0.00%)	2/57 (3.51%)
Dehydration ^†	0/62 (0.00%)	7/57 (12.28%)
Hyperglycemia ^†	0/62 (0.00%)	5/57 (8.77%)
Hyponatremia ^†	0/62 (0.00%)	2/57 (3.51%)
Hypophosphatemia ^†	0/62 (0.00%)	1/57 (1.75%)
Musculoskeletal and connective tissue disorders
Back pain ^†	0/62 (0.00%)	1/57 (1.75%)
Generalized muscle weakness ^†	0/62 (0.00%)	3/57 (5.26%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other ^†	0/62 (0.00%)	10/57 (17.54%)
Nervous system disorders
Cognitive disturbance ^†	0/62 (0.00%)	1/57 (1.75%)
Depressed level of consciousness ^†	0/62 (0.00%)	1/57 (1.75%)
Encephalopathy ^†	0/62 (0.00%)	1/57 (1.75%)
Stroke ^†	0/62 (0.00%)	1/57 (1.75%)
Syncope ^†	0/62 (0.00%)	2/57 (3.51%)
Respiratory, thoracic and mediastinal disorders
Epistaxis ^†	0/62 (0.00%)	1/57 (1.75%)
Hypoxia ^†	0/62 (0.00%)	1/57 (1.75%)
Skin and subcutaneous tissue disorders
Erythema multiforme ^†	0/62 (0.00%)	1/57 (1.75%)
Erythroderma ^†	0/62 (0.00%)	1/57 (1.75%)
Rash acneiform ^†	0/62 (0.00%)	2/57 (3.51%)
Rash maculo-papular ^†	0/62 (0.00%)	4/57 (7.02%)
Stevens-Johnson syndrome ^†	0/62 (0.00%)	1/57 (1.75%)
Vascular disorders
Hypertension ^†	0/62 (0.00%)	4/57 (7.02%)
Hypotension ^†	0/62 (0.00%)	2/57 (3.51%)
Thromboembolic event ^†	0/62 (0.00%)	3/57 (5.26%)
Visceral arterial ischemia ^†	1/62 (1.61%)	0/57 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	mFOLFOX	MK2206 and Selumetinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	56/62 (90.32%)	53/57 (92.98%)
Blood and lymphatic system disorders
Anemia ^†	26/62 (41.94%)	17/57 (29.82%)
Gastrointestinal disorders
Abdominal distension ^†	0/62 (0.00%)	3/57 (5.26%)
Abdominal pain ^†	26/62 (41.94%)	14/57 (24.56%)
Ascites ^†	1/62 (1.61%)	3/57 (5.26%)
Bloating ^†	5/62 (8.06%)	2/57 (3.51%)
Constipation ^†	25/62 (40.32%)	8/57 (14.04%)
Diarrhea ^†	23/62 (37.10%)	17/57 (29.82%)
Dry mouth ^†	0/62 (0.00%)	7/57 (12.28%)
Dyspepsia ^†	4/62 (6.45%)	4/57 (7.02%)
Flatulence ^†	1/62 (1.61%)	4/57 (7.02%)
Mucositis oral ^†	8/62 (12.90%)	12/57 (21.05%)
Nausea ^†	39/62 (62.90%)	25/57 (43.86%)
Vomiting ^†	21/62 (33.87%)	21/57 (36.84%)
General disorders
Chills ^†	2/62 (3.23%)	10/57 (17.54%)
Edema face ^†	0/62 (0.00%)	6/57 (10.53%)
Edema limbs ^†	6/62 (9.68%)	9/57 (15.79%)
Fatigue ^†	39/62 (62.90%)	25/57 (43.86%)
Fever ^†	4/62 (6.45%)	6/57 (10.53%)
Pain ^†	4/62 (6.45%)	0/57 (0.00%)
Infections and infestations
Infections and infestations-Other ^†	1/62 (1.61%)	6/57 (10.53%)
Investigations
Alanine aminotransferase increased ^†	9/62 (14.52%)	17/57 (29.82%)
Alkaline phosphatase increased ^†	18/62 (29.03%)	13/57 (22.81%)
Aspartate aminotransferase increased ^†	13/62 (20.97%)	20/57 (35.09%)
Blood bilirubin increased ^†	5/62 (8.06%)	3/57 (5.26%)
Creatinine increased ^†	3/62 (4.84%)	9/57 (15.79%)
Investigations-Other ^†	4/62 (6.45%)	4/57 (7.02%)
Lymphocyte count decreased ^†	15/62 (24.19%)	8/57 (14.04%)
Neutrophil count decreased ^†	12/62 (19.35%)	1/57 (1.75%)
Platelet count decreased ^†	21/62 (33.87%)	6/57 (10.53%)
Weight loss ^†	13/62 (20.97%)	6/57 (10.53%)
White blood cell decreased ^†	13/62 (20.97%)	1/57 (1.75%)
Metabolism and nutrition disorders
Anorexia ^†	25/62 (40.32%)	20/57 (35.09%)
Dehydration ^†	7/62 (11.29%)	6/57 (10.53%)
Hyperglycemia ^†	20/62 (32.26%)	22/57 (38.60%)
Hypoalbuminemia ^†	20/62 (32.26%)	17/57 (29.82%)
Hypocalcemia ^†	9/62 (14.52%)	7/57 (12.28%)
Hypokalemia ^†	11/62 (17.74%)	4/57 (7.02%)
Hypomagnesemia ^†	5/62 (8.06%)	2/57 (3.51%)
Hyponatremia ^†	10/62 (16.13%)	15/57 (26.32%)
Musculoskeletal and connective tissue disorders
Back pain ^†	10/62 (16.13%)	3/57 (5.26%)
Generalized muscle weakness ^†	4/62 (6.45%)	6/57 (10.53%)
Nervous system disorders
Dizziness ^†	4/62 (6.45%)	10/57 (17.54%)
Dysgeusia ^†	8/62 (12.90%)	8/57 (14.04%)
Headache ^†	6/62 (9.68%)	2/57 (3.51%)
Paresthesia ^†	7/62 (11.29%)	0/57 (0.00%)
Peripheral sensory neuropathy ^†	29/62 (46.77%)	4/57 (7.02%)
Psychiatric disorders
Anxiety ^†	5/62 (8.06%)	4/57 (7.02%)
Depression ^†	4/62 (6.45%)	4/57 (7.02%)
Insomnia ^†	8/62 (12.90%)	4/57 (7.02%)
Respiratory, thoracic and mediastinal disorders
Cough ^†	11/62 (17.74%)	2/57 (3.51%)
Dyspnea ^†	6/62 (9.68%)	7/57 (12.28%)
Pleural effusion ^†	1/62 (1.61%)	3/57 (5.26%)
Skin and subcutaneous tissue disorders
Alopecia ^†	12/62 (19.35%)	0/57 (0.00%)
Dry skin ^†	6/62 (9.68%)	5/57 (8.77%)
Pruritus ^†	2/62 (3.23%)	8/57 (14.04%)
Rash acneiform ^†	0/62 (0.00%)	9/57 (15.79%)
Rash maculo-papular ^†	3/62 (4.84%)	18/57 (31.58%)
Skin and subcutaneous tissue disorders - Other ^†	1/62 (1.61%)	3/57 (5.26%)
Vascular disorders
Hypertension ^†	8/62 (12.90%)	7/57 (12.28%)
Hypotension ^†	3/62 (4.84%)	4/57 (7.02%)
† 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 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

Layout table for Results Point of Contact information

Name/Title:	SWOG Statistician
Organization:	SWOG Statistical Center
Phone:	206-667-4408

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

Chung V, McDonough S, Philip PA, Cardin D, Wang-Gillam A, Hui L, Tejani MA, Seery TE, Dy IA, Al Baghdadi T, Hendifar AE, Doyle LA, Lowy AM, Guthrie KA, Blanke CD, Hochster HS. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy: SWOG S1115 Study Randomized Clinical Trial. JAMA Oncol. 2017 Apr 1;3(4):516-522. doi: 10.1001/jamaoncol.2016.5383.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01658943
Other Study ID Numbers:	NCI-2012-01993 NCI-2012-01993 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) SWOG-S1115 CDR0000737878 S1115 ( Other Identifier: SWOG ) S1115 ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract ) U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted:	August 3, 2012
First Posted:	August 7, 2012
Results First Submitted:	February 10, 2016
Results First Posted:	March 9, 2016
Last Update Posted:	March 9, 2016

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