Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

Conditions

• Colorectal Cancer

Interventions

DRUG

capecitabine

1650 mg/m\^2/day orally 5 days/week during radiotherapy.

DRUG

oxaliplatin

PROCEDURE

resection

All patients undergo surgery 4 to 8 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.

RADIATION

radiation therapy

Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx

DRUG

FOLFOX

Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m\^2, IV over 2 hours, day 1. Leucovorin 400 mg/m\^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m\^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m\^2, IV continuous infusion over 46 hours, day 1.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Michael C. Garofalo, MD · University of Maryland Greenebaum Cancer Center

• Adam C. Berger, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

• Johanna Bendell, MD · Duke Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2010-01-31

Completion

2016-12-31

Countries

• United States
• Canada

Study Locations