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NCT00335816 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Colorectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

Active
Registry status
Phase 2
Development phase
248
Enrollment target
15
Study locations

NCT00335816: Active Phase 2 study of Colorectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00335816 is a Phase 2 study of Colorectal Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 248 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (84% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00335816, a Phase 2 study of Colorectal Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
248 participants
Enrollment target
15
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin calcium
  • PROCEDURE conventional surgery
  • RADIATION radiation therapy

Study Locations (15)

California

  • Cancer Care Center at John Muir Health - Concord Campus - Concord
  • City of Hope Medical Center - Duarte
  • St. Joseph Hospital Regional Cancer Center - Orange - Orange
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center - Orange
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

District of Columbia

  • Washington Cancer Institute at Washington Hospital Center - Washington D.C.

Florida

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

Illinois

  • University of Chicago Cancer Research Center - Chicago

Minnesota

  • Masonic Cancer Center at University of Minnesota - Minneapolis

Missouri

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis - St Louis

Nebraska

  • Colon and Rectal Surgery, Incorporated - Omaha

Ohio

  • Cleveland Clinic Taussig Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 248 participants
Start Date 2008-08
Est. Completion 2026-12
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

What the Registry Record Tells You About NCT00335816

The ClinicalTrials.gov registry entry for NCT00335816 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which oxaliplatin is the first listed.

NCT00335816 reports 15 study locations spanning 11 distinct geographic areas - top geographies include California, District of Columbia, Florida.

Frequently Asked Questions

What is clinical trial NCT00335816 about?

NCT00335816 is a clinical study titled "Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer". 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...

What is the current status of trial NCT00335816?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2008-08. Estimated completion is 2026-12.

What conditions does trial NCT00335816 study?

This clinical trial studies the following conditions: Colorectal Cancer.

What interventions are being tested in trial NCT00335816?

The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00335816?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00335816 being conducted?

This trial has 15 study locations across California, District of Columbia, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.