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NCT00047008 · ClinicalTrials.gov registry record · Phase 3

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

A Phase 3 study of Head and Neck Cancer, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
743
Enrollment target
20
Study locations

NCT00047008 is a Phase 3 study of Head and Neck Cancer that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 743 participants, above the 258-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (188% higher). The trial reports 20 study locations across 3 states.

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The verdict

NCT00047008, a Phase 3 study of Head and Neck Cancer, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
743 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

Conditions Studied

Interventions

  • DRUG cisplatin
  • RADIATION Standard fractionation RT
  • RADIATION Accelerated fractionation radiation therapy
  • PROCEDURE Conventional surgery for select patients

Study Locations (20)

California

  • Providence Saint Joseph Medical Center - Burbank - Burbank
  • Saint Rose Hospital - Hayward
  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital - Inglewood
  • Valley Memorial Hospital - Livermore
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
  • USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
  • Providence Holy Cross Cancer Center - Mission Hills
  • Highland General Hospital - Oakland
  • CCOP - Bay Area Tumor Institute - Oakland
  • Summit Medical Center - Oakland
  • Pomona Valley Hospital Medical Center - Pomona
  • Radiological Associates of Sacramento Medical Group, Inc. - Sacramento
  • University of California Davis Cancer Center - Sacramento
  • Naval Medical Center - San Diego - San Diego

Arizona

  • Foundation for Cancer Research and Education - Phoenix
  • CCOP - Mayo Clinic Scottsdale Oncology Program - Scottsdale
  • Scottsdale Healthcare - Shea - Scottsdale
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn - Scottsdale

Alabama

  • Comprehensive Cancer Center at University of Alabama at Birmingham - Birmingham
  • Mobile Infirmary Medical Center - Mobile

Trial Details

FieldValue
Enrollment Target 743 participants
Start Date 2002-07
Est. Completion 2022-05-20
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00047008

The ClinicalTrials.gov registry entry for NCT00047008 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 743 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 258-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (188% higher). The listed sponsor is Radiation Therapy Oncology Group, which has 144 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.

NCT00047008 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT00047008 about?

NCT00047008 is a clinical study titled "Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer". RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surg...

What is the current status of trial NCT00047008?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2002-07. Estimated completion is 2022-05-20.

What conditions does trial NCT00047008 study?

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

What interventions are being tested in trial NCT00047008?

The interventions under investigation include: cisplatin (DRUG), Standard fractionation RT (RADIATION), Accelerated fractionation radiation therapy (RADIATION), Conventional surgery for select patients (PROCEDURE).

Who is sponsoring clinical trial NCT00047008?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00047008 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. 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 Editorial

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.