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ACTIVE NOT RECRUITING
NCT00335816
PHASE2

Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy. Leucovorin calcium may protect normal cells from the side effects of chemotherapy, and it may help fluorouracil work better by making tumor cells more sensitive to the drug. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

Official title: Timing of Rectal Cancer Response to Chemoradiation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2008-08

Completion Date

2026-12

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DRUG

fluorouracil

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

oxaliplatin

Given IV

PROCEDURE

conventional surgery

Patients undergo surgery

RADIATION

radiation therapy

Patients undergo radiotherapy

OTHER

laboratory biomarker analysis

Correlative studies

GENETIC

DNA analysis

Correlative studies

GENETIC

polymerase chain reaction

Correlative studies

OTHER

immunohistochemistry staining method

Correlative studies

Locations (15)

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, United States

City of Hope Medical Center

Duarte, California, United States

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Colon and Rectal Surgery, Incorporated

Omaha, Nebraska, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada