Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer.

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

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the rectum

• Tumor extending through bowel wall (T3) OR

• Fixation to surrounding structures (T4) OR

• Nodal involvement by endorectal ultrasound (N1-2)

• Tumor extending through bowel wall, but not fixed (T3) must be:

• At least 4 cm or at least 40% of bowel circumference OR

• Accompanied by nodal involvement

• Evidence of transmural penetration confirmed by 2 of the following:

• CT scan

• Pelvic MRI

• Transrectal ultrasound

• Physical exam

• Proximal extent of tumor must not extend higher than 12 cm above dentate line and must be below pelvic peritoneal reflexion or sacral promontory

• Regional lymph node involvement allowed

• No distant metastases by CT scan of abdomen and pelvis or chest x-ray

PATIENT CHARACTERISTICS:

• Age: Over 18

• Performance status: ECOG 0-1

• Life expectancy: At least 2 years

• Hematopoietic:

• Leukocyte count greater than 4,000/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 10 g/dL

• Hepatic:

• SGOT and SGPT less than 1.5 times normal

• Bilirubin less than 1.5 mg/dL

• Renal: Creatinine less than 1.8 mg/dL

• Other:

• Not pregnant or nursing

• Negative pregnancy test

• No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix

• No psychiatric condition that would preclude informed consent

• No other serious medical illness that would limit survival

PRIOR CONCURRENT THERAPY:

• Biologic therapy: Not specified

• Chemotherapy: No prior chemotherapy for rectal cancer

• Endocrine therapy: Not specified

• Radiotherapy: No prior radiotherapy for rectal cancer

• Surgery: No prior surgery for rectal cancer, except diagnostic biopsy