Clinical trialNCT00613080CompletedPhase 2Interventional

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

SponsorRadiation Therapy Oncology GroupEnrollment79Colorectal Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Adam C. Berger, MD
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study Chair
clinicaltrials.gov ↗
Johanna Bendell, MD
Duke Cancer Institute
Study ChairKOL profile →
clinicaltrials.gov ↗
Michael C. Garofalo, MD
University of Maryland Greenebaum Cancer Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

120 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada

United States

Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States
Auburn Radiation Oncology
Auburn, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center - Woodward Park Office
Fresno, California, United States
Rebecca and John Moores Ucsd Cancer Center
La Jolla, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Mercy General Hospital
Sacramento, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States
Bay Medical
Panama City, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Cancer Institute at St. John'S Hospital
Springfield, Illinois, United States
Saint John'S Cancer Center at Saint John'S Medical Center
Anderson, Indiana, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States
St. Vincent Oncology Center
Indianapolis, Indiana, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke'S Hospital - South
Overland Park, Kansas, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Dana-Farber/brigham and Women'S Cancer Center
Boston, Massachusetts, United States
Dana-Farber/harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne'S Hospital - Fall River
Fall River, Massachusetts, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States

80 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Folfox →Capecitabine →Oxaliplatin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Apr 2008
Primary completion: 31 Jan 2010
Completion: 31 Dec 2016
Last update posted: 25 Sept 2018
Registered enrollment: 79
Registry id: NCT00613080

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.