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

PHASE2CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

May 31, 2011

Study Completion Date

December 31, 2016

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.

Trial Locations (5)

18512

Northeast Radiation Oncology Center, Dunmore

33176

Baptist-South Miami Regional Cancer Program, Miami

60426

Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey

95817

University of California Davis Cancer Center, Sacramento

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Radiation Therapy Oncology Group

NETWORK

NCT00081289 - Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter