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NCT00004246 · ClinicalTrials.gov registry record · Phase 1

Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00004246: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00004246 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004246, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.

Primary Outcome

MTD based on systemic toxicity of drug and acute mucosal reactions in the irradiated fields.

Interventions

  • DRUG Fludarabine Phosphate
  • RADIATION Radiation Therapy (RT)

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 1995-06-07
Est. Completion 2002-12-02
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00004246 record still lists

NCT00004246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Fludarabine Phosphate is the first listed.

NCT00004246 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004246 about?

NCT00004246 is a clinical study titled "Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effec...

What is the current status of trial NCT00004246?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 1995-06-07. Estimated completion is 2002-12-02.

What interventions are being tested in trial NCT00004246?

The interventions under investigation include: Fludarabine Phosphate (DRUG), Radiation Therapy (RT) (RADIATION).

Who is sponsoring clinical trial NCT00004246?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004246's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00004246, the US trial registry maintained by the National Library of Medicine. NCT00004246 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.