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Active, not recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00335816

Public ClinicalTrials.gov record NCT00335816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 5:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Timing of Rectal Cancer Response to Chemoradiation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00335816
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
248 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2008
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026
Last update posted
Jan 13, 2026

2008 – 2026

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Cancer Care Center at John Muir Health - Concord Campus Concord California 94524-4110
City of Hope Medical Center Duarte California 91010-3000
St. Joseph Hospital Regional Cancer Center - Orange Orange California 92868-3849
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California 92868
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94115
Washington Cancer Institute at Washington Hospital Center Washington D.C. District of Columbia 20010
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida 33612-9497
University of Chicago Cancer Research Center Chicago Illinois 60637-1470
Masonic Cancer Center at University of Minnesota Minneapolis Minnesota 55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St Louis Missouri 63110
Colon and Rectal Surgery, Incorporated Omaha Nebraska 68114
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195
Knight Cancer Institute at Oregon Health and Science University Portland Oregon 97239-3098
Vermont Cancer Center at University of Vermont Burlington Vermont 05405-0110

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00335816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 13, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00335816 live on ClinicalTrials.gov.

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