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NCT00095875 · ClinicalTrials.gov registry record · Phase 3

Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)

A Phase 3 study of Head and Neck Cancer, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 3
Development phase
145
Enrollment target
15
Study locations

NCT00095875 is a Phase 3 study of Head and Neck Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 145 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (44% lower). The trial reports 15 study locations across 15 states.

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The verdict

NCT00095875, a Phase 3 study of Head and Neck Cancer, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 3
Development phase
145 participants
Enrollment target
15
Study locations

Study Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

Conditions Studied

Head and Neck Cancer

Interventions

  • DRUG cisplatin
  • DRUG carboplatin
  • DRUG docetaxel
  • DRUG fluorouracil

Study Locations (15)

California

  • Rebecca and John Moores UCSD Cancer Center - La Jolla

Colorado

  • CCOP - Colorado Cancer Research Program - Denver

Florida

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus - Boca Raton

Georgia

  • Winship Cancer Institute of Emory University - Atlanta

Illinois

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center - Maywood

Maine

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough - Scarborough

Maryland

  • Greenebaum Cancer Center at University of Maryland Medical Center - Baltimore

Massachusetts

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2004-08
Est. Completion 2012-04
Phase Phase 3

Sponsor

Dana-Farber Cancer Institute

781 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00095875

The ClinicalTrials.gov registry entry for NCT00095875 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (44% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which cisplatin is the first listed.

NCT00095875 reports 15 study locations spanning 15 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT00095875 about?

NCT00095875 is a clinical study titled "Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)". RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may...

What is the current status of trial NCT00095875?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2004-08. Estimated completion is 2012-04.

What conditions does trial NCT00095875 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT00095875?

The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), docetaxel (DRUG), fluorouracil (DRUG).

Who is sponsoring clinical trial NCT00095875?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00095875 being conducted?

This trial has 15 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.