Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been 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: NCT00002593
Recruitment Status : Completed
First Posted : August 31, 2004
Last Update Posted : January 3, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE August 31, 2004
Last Update Posted Date January 3, 2013
Study Start Date  ICMJE December 1994
Actual Primary Completion Date December 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Compare effectiveness of bolus 5-FU, leucovorin, levamisole vs continuous infusion 5-FU, levamisole as adjuvant therapy for patients with colon cancer, measured in overall survival [ Time Frame: At death ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Disease free survival [ Time Frame: Until progression ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed
Official Title  ICMJE Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in different ways in treating patients with surgically removed stage II or stage III colon cancer at high risk of recurrence.

Detailed Description

OBJECTIVES: I. Compare overall and disease free survival in patients with completely resected stage II or III colon cancer randomized to adjuvant chemotherapy with bolus fluorouracil and leucovorin calcium with levamisole vs continuous infusion fluorouracil with levamisole.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, T stage (T1 vs T2 vs T3 vs T4a), N stage (N0 vs N1 vs N2-3), and time from surgery until registration (21-28 vs 29-35 days). Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV immediately followed by fluorouracil IV on days 1 through 5 of weeks 1, 5, 9, 14, 19, and 24, and oral levamisole 3 times a day for 3 days on days 1-3. Courses repeat every 2 weeks for 6 months. Arm II: Patients receive levamisole as in arm I plus fluorouracil by continuous IV infusion for 8 weeks. Treatment with fluorouracil repeats every 10 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 9 months and 12 months, then every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the study over approximately 5.5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: fluorouracil
    Given IV as described in Arm Description
    Other Names:
    • 5-fluorouracil
    • 5-FU
    • NSC-19893
  • Drug: leucovorin calcium
    Given IV as described in Arm description.
    Other Names:
    • Leucovorin
    • Folinic acid
    • NSC-3590
  • Drug: levamisole hydrochloride
    Given as described in arm description
    Other Names:
    • Levamisole
    • NSC-177023
Study Arms  ICMJE
  • Active Comparator: 5-FU/Leucovorin/Levamisole
    levamisole hydrochloride: 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; leucovorin calcium: 20 mg/m^2/day, IV, Days 1-5 of each cycle; 5-fluorouracil: 425 mg/m^2/day, IV, Days 1-5 of each cycle;
    Interventions:
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: levamisole hydrochloride
  • Active Comparator: Infusional 5-FU + Levamisole
    levamisole hydrochloride : 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; 5-fluorouracil: 250 mg/m^2/day, continuous infusion, daily for 56 days x 3 cycles of 8 weeks.
    Interventions:
    • Drug: fluorouracil
    • Drug: levamisole hydrochloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2013)
1135
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date December 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Histologically proven resectable stage II or III adenocarcinoma of the colon Caudal margin of the primary tumor must lie above the peritoneal reflection Must have pathologic confirmation of either N1-3 (stage III), or if N0, must have T3-T4 (stage II) with bowel obstruction or perforation Obstruction documented as: At least 75% colon or small bowel obstruction on x-ray and/or endoscopy Significant bowel dilatation surgically documented Significant obstruction described in the pathology report Perforation documented by gross operative/pathologic evidence of a colon wall defect with associated abscess or peritonitis Complete en bloc resection by laparotomy required No laparoscopic colectomy without prior surgery on protocol SWOG-9411 No gross or microscopic residual disease No distant peritoneal metastases (stage IV) even if grossly resectable No requirement to open the pelvic peritoneum to define the extent of disease No extrapelvic nodal metastasis unless resected en bloc with the primary tumor No distant metastases No other diagnosis of stage II-III colon cancer within the past 5 years May have undergone complete surgical resection at least 5 years prior to study Completely resected prior or synchronous stage 0-I colon cancer eligible

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: WBC (white blood cell) at least 3,500/mm3 Platelet count at least within the lower limit of normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST (angiotensin sensitivity test) no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: No organic brain syndrome, Alzheimer's disease, or other altered mental status No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior fluorouracil or other chemotherapy for cancer No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy for cancer Surgery: Complete en bloc resection required (see Disease Characteristics)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002593
Other Study ID Numbers  ICMJE CDR0000063773
SWOG-9415 ( Other Identifier: SWOG )
CLB-9498 ( Other Identifier: CALGB )
INT-0153 ( Other Identifier: NCI )
U10CA032102 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Cancer and Leukemia Group B
  • Eastern Cooperative Oncology Group
  • North Central Cancer Treatment Group
Investigators  ICMJE
Study Chair: Elizabeth A. Poplin, MD Rutgers Cancer Institute of New Jersey
Study Chair: Robert J. Mayer, MD, FACP Dana-Farber Cancer Institute
Study Chair: Daniel G. Haller, MD Abramson Cancer Center of the University of Pennsylvania
Study Chair: Richard M. Goldberg, MD Mayo Clinic
PRS Account Southwest Oncology Group
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP