S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Capecitabine; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin; Pyridoxine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary adenocarcinoma of the rectum

• Locally advanced disease (clinical T3-4, N0-2, M0) based on at least 1 of the following criteria:

• Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall and/or sacrum

• Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane is considered evidence of fixation

• Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder invasion by cystoscopy and cytology or biopsy

• Invasion into the prostate, vagina, or uterus

• Transmural penetration of tumor through the muscularis propria as evidenced by CT scan or MRI and endorectal ultrasound

• Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm of the anal verge) by proctoscopic examination

• Measurable disease by x-ray, scans, or physical examination

• Available tumor tissue to determine molecular profile of the tumor before study treatment

• No clinical evidence of high-grade (lumen diameter < 1 cm) large bowel obstruction unless a diverting colostomy has been performed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,500/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT or SGPT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• See Disease Characteristics

• Creatinine ≤ 1.5 times ULN OR

• Estimated creatinine clearance > 50 mL/min

Cardiovascular

• No significant cardiac disease

• No recent myocardial infarction

Gastrointestinal

• See Disease Characteristics

• Able to swallow oral medication

• No active inflammatory bowel disease

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No prior unanticipated severe reaction to study drugs

• No known dihydropyrimidine dehydrogenase deficiency

• No serious uncontrolled infection

• No other serious medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for colon or rectal cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic radiotherapy

• No prior intra-operative radiotherapy or brachytherapy

• No concurrent intra-operative radiotherapy or brachytherapy

• No concurrent intensity-modulated radiotherapy

Surgery

• See Disease Characteristics

• See Radiotherapy