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NCT00265941 · ClinicalTrials.gov registry record · Phase 3

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer

A Phase 3 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
940
Enrollment target

NCT00265941 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 940 participants.

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The verdict

NCT00265941, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
940 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.

Interventions

  • DRUG cetuximab
  • DRUG cisplatin
  • RADIATION Intensity-modulated radiation therapy
  • RADIATION Accelerated Fractionation by Concomitant Boost

Trial Details

FieldValue
Enrollment Target 940 participants
Start Date 2005-11
Est. Completion 2022-05-20
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00265941

The ClinicalTrials.gov registry entry for NCT00265941 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 940 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

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

NCT00265941 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00265941 about?

NCT00265941 is a clinical study titled "Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radi...

What is the current status of trial NCT00265941?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 940 participants. The study started on 2005-11. Estimated completion is 2022-05-20.

What interventions are being tested in trial NCT00265941?

The interventions under investigation include: cetuximab (DRUG), cisplatin (DRUG), Intensity-modulated radiation therapy (RADIATION), Accelerated Fractionation by Concomitant Boost (RADIATION).

Who is sponsoring clinical trial NCT00265941?

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

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.