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NCT00084591 · ClinicalTrials.gov registry record · Phase 1

Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer

A Phase 1 study, sponsored by Fox Chase Cancer Center.

Completed
Registry status
Phase 1
Development phase

NCT00084591 is a Phase 1 study that has completed, run by Fox Chase Cancer Center.

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The verdict

NCT00084591, a Phase 1 study, has completed, sponsored by Fox Chase Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer.

Interventions

  • DRUG capecitabine
  • PROCEDURE conventional surgery
  • RADIATION radiation therapy
  • PROCEDURE neoadjuvant therapy

Trial Details

FieldValue
Start Date 2003-12
Est. Completion 2007-02
Phase Phase 1

Sponsor

Fox Chase Cancer Center

183 total trials

What the Registry Record Tells You About NCT00084591

The ClinicalTrials.gov registry entry for NCT00084591 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which capecitabine is the first listed.

NCT00084591 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00084591 about?

NCT00084591 is a clinical study titled "Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may cause less...

What is the current status of trial NCT00084591?

This trial is currently completed. It is a Phase 1 study. The study started on 2003-12. Estimated completion is 2007-02.

What interventions are being tested in trial NCT00084591?

The interventions under investigation include: capecitabine (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), neoadjuvant therapy (PROCEDURE).

Who is sponsoring clinical trial NCT00084591?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

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, or report a data error.