Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT Plus Bolus 5-FU Plus Leucovorin in Patients With Rectal Cancer, Phase III

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage II or III adenocarcinoma of the
rectum Tumor extends through the bowel wall and into perirectal fat or soft tissue (TNM
T3-4, N0, M0) Nodes are involved with tumor (TNM T1-4, N1-3, M0) Tumor completely resected
en bloc with no gross or microscopic evidence of residual disease Circumferential (radial)
margins of resected adherent tumors must be specifically documented free of disease (with
the sole exception of extraperitoneal serosal margins) No evidence of metastasis No
regional nodal metastases (metastases outside of the pelvis) that cannot be resected en
bloc with the primary lesion No distant peritoneal metastases (metastases that are not a
direct extension from the primary tumor) even if grossly resected (direct extension into
another structure permitted) Abdominopelvic CT required unless: Bilirubin, SGOT, and
alkaline phosphatase are within normal limits, AND Operative report describes liver as
normal on exploration No tumors of colonic origin, i.e.: Lower edge of the tumor is below
the peritoneal reflection or a portion of the tumor is retroperitoneally located (usually
posteriorly) as defined by the surgeon at laparotomy OR Lower margin of the tumor is 12 cm
or less from the anal verge by proctoscopic exam No prior history of rectal cancer No
stage II or III cancers of the extrapelvic colon within the past 5 years Complete surgical
resection at least 5 years prior to protocol registration allowed provided no other
therapy was administered Synchronous modified stage I or IIa colorectal cancer (no nodal
involvement or penetration through the muscularis propria) that has been completely
resected allowed Registration between 20 and 70 days after the definitive surgical
procedure required Chemotherapy must begin no later than day 70 following surgery
Concurrent registration on protocol SWOG-9419 allowed for patients with adequate tissue
samples

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Hematopoietic: WBC at
least 4,000/mm3 Platelet count normal Hepatic: Bilirubin no greater than 2 times upper
limit of normal (ULN) SGOT no greater than 2 times ULN Alkaline phosphatase no greater
than 2 times ULN Renal: Not specified Other: No chronic ulcerative colitis No other
serious medical illness that would preclude protocol therapy No psychiatric condition that
would preclude informed consent No noncolorectal 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 Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics Other: No other concurrent antineoplastic therapy