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NCT00004227 · ClinicalTrials.gov registry record · Phase 3

Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx

A Phase 3 study, sponsored by University of Alabama at Birmingham.

Terminated
Registry status
Phase 3
Development phase
32
Enrollment target

NCT00004227: Clinical Trial Phase 3 study, sponsored by University of Alabama at Birmingham.

NCT00004227 is a Phase 3 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004227, a Phase 3 study, was terminated before completion, sponsored by University of Alabama at Birmingham.

TERMINATED
Registry status
Phase 3
Development phase
32 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.

Interventions

  • BIOLOGICAL cetuximab
  • PROCEDURE conventional surgery
  • RADIATION radiation therapy

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 1999-04
Est. Completion 2008-05
Phase Phase 3
University of Alabama at Birmingham

1,160 total trials

Why NCT00004227 stopped before completion

NCT00004227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which cetuximab is the first listed.

NCT00004227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004227 about?

NCT00004227 is a clinical study titled "Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or...

What is the current status of trial NCT00004227?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 1999-04. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00004227?

The interventions under investigation include: cetuximab (BIOLOGICAL), conventional surgery (PROCEDURE), radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00004227?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004227's enrollment target sits among peer trials

32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00004227, the US trial registry maintained by the National Library of Medicine. NCT00004227 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.