Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Intervention: fluorouracil; leucovorin calcium
Intervention description: 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; given after surgery at dose of 20mg/m^2 IV push on days 1-5
Intervention MeSH terms: Leucovorin; Tetrahydrofolates; Formyltetrahydrofolates; Fluorouracil; Calcium; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 859.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II colon cancer; stage III colon cancer

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 tumor cells. It is not yet known if surgery is more effective with or without
      chemotherapy for colon cancer.

      PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU)
      chemotherapy after curative resection could improve overall survival and disease-free
      survival in patients with Duke's B3 or C colon cancer.
    

Eligibility criteria:

        Eligibility Criteria for Randomization:

        Inclusion Criteria:

          -  Adenocarcinoma of the colon documented by colonoscopy or barium enema

          -  Tumor either considered resectable or totally resected within 24 hours prior to study

          -  Randomization within 2 weeks prior to surgery or within 24 hours after surgery
             required

          -  Patients randomized after surgery must meet the following criteria:

               -  Complete resection performed with no evidence of residual disease or distant
                  metastases

               -  Distal margin of tumor above the peritoneal reflection in area of rectum

               -  No free perforation Intestinal obstruction allowed

               -  Preliminary or complementary colostomy allowed

          -  Concurrent registration for E3293 strongly recommended

          -  Age 18 and over

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Adequate organ function based on the following tests within 2 weeks prior to
             randomization

               -  White Blood Cell (WBC) at least 3,000/mm^3

               -  Platelet count at least 100,000/mm^3

               -  Bilirubin no greater than 2.0 mg/dL

               -  Creatinine no greater than 2.0 mg/dL

          -  No second malignancy within 5 years except: superficial non-melanomatous skin cancer
             and carcinoma in situ of the cervix

          -  Fertile patients must use adequate contraception

        Exclusion Criteria:

          -  Dual primary tumors

          -  Prior nonmalignant systemic disease that would preclude use of chemotherapy

          -  Pregnant or nursing

          -  Prior fluorouracil

          -  Other prior or concurrent chemotherapy for this malignancy

          -  Prior or concurrent radiotherapy for this malignancy

        Eligibility Criteria for Re-registration for Patients Randomized Pre-operatively:

          -  Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing
             institution.

          -  Must be re-registered < 35 days after surgery.

          -  ECOG performance status of 0-2.

          -  Complete resection must have been performed with no evidence of residual disease or
             distant metastasis.

          -  Distal margin of the tumor must not extend below the peritoneal reflection in the area
             of the rectum.

          -  Single primary colon carcinoma without free perforation demonstrated. Patients with
             intestinal obstruction are eligible. Preliminary or complementary colostomy dose not
             preclude entry of a patient.

          -  Have WBC > 3000/mm^3, platelets > 100,000/mm^3, adequate renal (serum creatinine <=
             2.0mg/dL) and hepatic function (bilirubin <= 2.0mg/dL), within one week prior to
             beginning adjuvant chemotherapy (For Dukes' B3 and C patients only).

        Eligibility Criteria for Re-registration for Patients Randomized Post-operatively:

          -  Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing
             institution.

          -  Patient must be re-registered < 35 days after surgery.

          -  ECOG performance status of 0-2.

          -  Started perioperative 5-FU, if assigned, within 24 hours of surgery.

          -  Have WBC > 3000/mm^3, platelets > 100,000/mm^3, adequate renal (serum creatinine <=
             2.0mg/dL) and hepatic function (bilirubin < =2.0mg/dL), within one week prior to
             beginning adjuvant chemotherapy (For Dukes' B3 and C patients only).