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Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002525
Recruitment Status : Terminated (The study was stopped before reaching its accrual goal due to slow accrual)
First Posted : April 6, 2004
Results First Posted : July 20, 2016
Last Update Posted : August 29, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Cancer and Leukemia Group B
American College of Surgeons
NSABP Foundation Inc
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: fluorouracil
Drug: leucovorin calcium
Enrollment 859
Recruitment Details This study was activated on August 20, 1993 and was terminated on May 19, 2000 before reaching its accrual goal due slow accrual. The final accrual for the study was 859 patients.
Pre-assignment Details  
Arm/Group Title Perioperative 5-FU No Perioperative 5-FU
Hide Arm/Group Description

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Period Title: Overall Study
Started 427 [1] 428
Treated 419 0 [2]
Dukes' B3 or C Stage 156 [3] 158
Dukes' B2 Stage 150 139
Completed 241 428 [2]
Not Completed 186 0
Reason Not Completed
Adverse Event             36             0
Death             5             0
Withdrawal by Subject             11             0
Start non-protocol therapy             1             0
Other complicating disease             1             0
Duke's A, B1, D disease             92             0
Error             6             0
Other             26             0
Never start protocol therapy             8             0
[1]
859 patients were enrolled to the study, but 4 patients were not randomized to any treatment arm
[2]
Patients on "No perioperative 5-FU arm" received no perioperative chemotherapy
[3]
Primary population: pts with Duke's B3, C disease. 158 such pts on "No perioperative 5-FU arm"
Arm/Group Title Perioperative 5-FU No Perioperative 5-FU Total
Hide Arm/Group Description

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Total of all reporting groups
Overall Number of Baseline Participants 156 158 314
Hide Baseline Analysis Population Description
The primary analysis population for the study was all randomized patients with Duke's B3 and C disease.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 156 participants 158 participants 314 participants
63
(30 to 89)
66
(25 to 86)
65
(25 to 89)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 158 participants 314 participants
Female 57 61 118
Male 99 96 195
[1]
Measure Description: 1 patient on "No perioperative 5-FU arm" had missing information about sex
1.Primary Outcome
Title 5-year Overall Survival Rate in Patients With Dukes' B3/C Disease
Hide Description Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate
Time Frame every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with Dukes' B3 and C disease
Arm/Group Title Perioperative 5-FU No Perioperative 5-FU
Hide Arm/Group Description:

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Overall Number of Participants Analyzed 156 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.666
(0.585 to 0.735)
0.612
(0.530 to 0.683)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perioperative 5-FU, No Perioperative 5-FU
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments one-sided log-rank test p value
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title 5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease
Hide Description Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.
Time Frame every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with Dukes' B3 and C disease who had complete disease assessment data
Arm/Group Title Perioperative 5-FU No Perioperative 5-FU
Hide Arm/Group Description:

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Overall Number of Participants Analyzed 128 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.582
(0.486 to 0.668)
0.543
(0.442 to 0.634)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perioperative 5-FU, No Perioperative 5-FU
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments two-sided log rank test
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title 5-year Overall Survival Rate in Patients With Dukes' B2 Disease
Hide Description Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate
Time Frame every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with Dukes' B2 disease
Arm/Group Title Perioperative 5-FU No Perioperative 5-FU
Hide Arm/Group Description:

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Overall Number of Participants Analyzed 150 139
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.851
(0.783 to 0.899)
0.780
(0.701 to 0.841)
4.Secondary Outcome
Title 5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease
Hide Description Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.
Time Frame every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with Dukes' B2 disease who had complete disease assessment data
Arm/Group Title Perioperative 5-FU No Perioperative 5-FU
Hide Arm/Group Description:

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Overall Number of Participants Analyzed 133 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.749
(0.660 to 0.818)
0.724
(0.626 to 0.801)
Time Frame Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy.
Adverse Event Reporting Description After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
 
Arm/Group Title Arm I (Perioperative 5-FU) Arm II (No Perioperative 5-FU) Adjuvant Chemotherapy-- 5-FU+Levamisolem Adjuvant Chemotherapy-- 5-FU+Leucovovin
Hide Arm/Group Description

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Patients receive no perioperative fluorouracil.

After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5

fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery

After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5

leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5

Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:

Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin

A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.

All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis.

After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:

Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.

5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.

All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis.

All-Cause Mortality
Arm I (Perioperative 5-FU) Arm II (No Perioperative 5-FU) Adjuvant Chemotherapy-- 5-FU+Levamisolem Adjuvant Chemotherapy-- 5-FU+Leucovovin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Perioperative 5-FU) Arm II (No Perioperative 5-FU) Adjuvant Chemotherapy-- 5-FU+Levamisolem Adjuvant Chemotherapy-- 5-FU+Leucovovin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/418 (17.94%)   4/422 (0.95%)   76/171 (44.44%)   32/61 (52.46%) 
Blood and lymphatic system disorders         
Anemia  2  22/418 (5.26%)  0/422 (0.00%)  1/171 (0.58%)  1/61 (1.64%) 
Phlebitis  2  0/418 (0.00%)  0/422 (0.00%)  5/171 (2.92%)  2/61 (3.28%) 
Cardiac disorders         
Cardiac  2  9/418 (2.15%)  0/422 (0.00%)  2/171 (1.17%)  2/61 (3.28%) 
Gastrointestinal disorders         
Nausea/Vomiting  1  7/418 (1.67%)  0/422 (0.00%)  8/171 (4.68%)  4/61 (6.56%) 
Vomiting  2  6/418 (1.44%)  0/422 (0.00%)  5/171 (2.92%)  2/61 (3.28%) 
Diarrhea  2  14/418 (3.35%)  0/422 (0.00%)  20/171 (11.70%)  15/61 (24.59%) 
Stomatitis  2  11/418 (2.63%)  0/422 (0.00%)  6/171 (3.51%)  9/61 (14.75%) 
General disorders         
Others  2  0/418 (0.00%)  2/422 (0.47%)  7/171 (4.09%)  6/61 (9.84%) 
Hepatobiliary disorders         
Liver  2  2/418 (0.48%)  0/422 (0.00%)  5/171 (2.92%)  1/61 (1.64%) 
Infections and infestations         
Infection  2  9/418 (2.15%)  0/422 (0.00%)  1/171 (0.58%)  3/61 (4.92%) 
Investigations         
Leukopenia  1  3/418 (0.72%)  1/422 (0.24%)  23/171 (13.45%)  8/61 (13.11%) 
Granulocytopenia  1  1/418 (0.24%)  0/422 (0.00%)  4/171 (2.34%)  1/61 (1.64%) 
Nervous system disorders         
Neuro-sensory  2  0/418 (0.00%)  1/422 (0.24%)  3/171 (1.75%)  0/61 (0.00%) 
Neuro-motor  2  6/418 (1.44%)  0/422 (0.00%)  1/171 (0.58%)  4/61 (6.56%) 
Neuro-psych  2  1/418 (0.24%)  0/422 (0.00%)  3/171 (1.75%)  1/61 (1.64%) 
Neuro-clinical  2  0/418 (0.00%)  0/422 (0.00%)  6/171 (3.51%)  3/61 (4.92%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary  2  4/418 (0.96%)  0/422 (0.00%)  1/171 (0.58%)  1/61 (1.64%) 
Skin and subcutaneous tissue disorders         
Skin  2  2/418 (0.48%)  0/422 (0.00%)  3/171 (1.75%)  3/61 (4.92%) 
Alopecia  2  0/418 (0.00%)  0/422 (0.00%)  1/171 (0.58%)  0/61 (0.00%) 
Vascular disorders         
Hypertension  2  1/418 (0.24%)  0/422 (0.00%)  1/171 (0.58%)  0/61 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
2
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Perioperative 5-FU) Arm II (No Perioperative 5-FU) Adjuvant Chemotherapy-- 5-FU+Levamisolem Adjuvant Chemotherapy-- 5-FU+Leucovovin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   236/418 (56.46%)   9/422 (2.13%)   167/171 (97.66%)   58/61 (95.08%) 
Blood and lymphatic system disorders         
Anemia  1  209/418 (50.00%)  7/422 (1.66%)  105/171 (61.40%)  43/61 (70.49%) 
Gastrointestinal disorders         
Nausea/vomiting  1  116/418 (27.75%)  4/422 (0.95%)  94/171 (54.97%)  27/61 (44.26%) 
Vomiting  1  60/418 (14.35%)  3/422 (0.71%)  45/171 (26.32%)  11/61 (18.03%) 
Diarrhea  1  67/418 (16.03%)  3/422 (0.71%)  74/171 (43.27%)  27/61 (44.26%) 
Stomatitis  1  71/418 (16.99%)  1/422 (0.24%)  59/171 (34.50%)  20/61 (32.79%) 
General disorders         
Fever (No Infection)  1  45/418 (10.77%)  1/422 (0.24%)  15/171 (8.77%)  7/61 (11.48%) 
Infections and infestations         
Infection  1  0/418 (0.00%)  0/422 (0.00%)  33/171 (19.30%)  9/61 (14.75%) 
Investigations         
Leukopenia  1  25/418 (5.98%)  2/422 (0.47%)  78/171 (45.61%)  32/61 (52.46%) 
Thrombocytopenia  1  24/418 (5.74%)  0/422 (0.00%)  66/171 (38.60%)  14/61 (22.95%) 
Nervous system disorders         
Neuro-clinical  1  21/418 (5.02%)  1/422 (0.24%)  84/171 (49.12%)  18/61 (29.51%) 
Neuro-motor  1  6/418 (1.44%)  0/422 (0.00%)  33/171 (19.30%)  3/61 (4.92%) 
Neuro-psych  1  9/418 (2.15%)  1/422 (0.24%)  17/171 (9.94%)  5/61 (8.20%) 
Skin and subcutaneous tissue disorders         
Skin  1  39/418 (9.33%)  2/422 (0.47%)  73/171 (42.69%)  24/61 (39.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
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
Name/Title: Study statistician
Organization: ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Publications of Results:
Kemeny M, Ibrahim J, Benson AB, et al.: Post-operative complications of continuous infusion 5 FU following curative resection of colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A923, 260a, 1997.
Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00002525     History of Changes
Other Study ID Numbers: E1292
E1292 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA023318 ( U.S. NIH Grant/Contract )
CDR0000078337 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 1, 1999
First Posted: April 6, 2004
Results First Submitted: April 8, 2016
Results First Posted: July 20, 2016
Last Update Posted: August 29, 2016