Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

Summary

RATIONALE: Drugs used in chemotherapy work in 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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

Conditions

• Colorectal Cancer

Interventions

RADIATION

Radiation Therapy

Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy.

DRUG

Capecitabine 1650 mg/m^2/day

825 mg/m\^2 q12 hours (1650 mg/m\^2/day) orally 5 days per week during radiotherapy.

DRUG

Capecitabine 1200 mg/m^2/day

600 mg/m\^2 q12 hours(1200 mg/m\^2/day) orally 5 days per week during radiotherapy.

DRUG

Irinotecan

50mg/m\^2 IV over 1 hour on days 1, 8, 22, and 29

DRUG

Oxaliplatin

50mg/m\^2 IV over 2 hours on days 1, 8, 15, 22, and 29

PROCEDURE

Surgery

All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon.

DRUG

Folinic Acid

400 mg/m\^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles.

DRUG

Fluorouracil

5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles. 5-fluorouracil infusion 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles.

DRUG

Oxaliplatin

85 mg/m\^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Neal J. Meropol, MD · Fox Chase Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-03-31

Primary Completion

2011-05-31

Completion

2016-12-31

Countries

• United States

Study Locations