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NCT00003582 · ClinicalTrials.gov registry record · Phase 1

Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer

A Phase 1 study of Head and Neck Cancer and Carcinoma of Unknown Primary, sponsored by University of Miami.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT00003582: Completed Phase 1 study of Head and Neck Cancer and Carcinoma of Unknown Primary, sponsored by University of Miami.

NCT00003582 is a Phase 1 study of Head and Neck Cancer and Carcinoma of Unknown Primary that has completed, run by University of Miami. The registered enrollment target is 36 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003582, a Phase 1 study of Head and Neck Cancer and Carcinoma of Unknown Primary, has completed, sponsored by University of Miami.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

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. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy and chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV head and neck cancer that cannot be surgically removed.

Interventions

  • DRUG cisplatin
  • DRUG paclitaxel
  • PROCEDURE quality-of-life assessment
  • DRUG fluorouracil
  • DRUG amifostine trihydrate

Study Locations (1)

Florida

  • Sylvester Cancer Center, University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 1988-05
Est. Completion 1996-12
Phase Phase 1
University of Miami

721 total trials

What the finished NCT00003582 record still lists

NCT00003582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower).

The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which cisplatin is the first listed.

NCT00003582 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT00003582 about?

NCT00003582 is a clinical study titled "Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer". 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. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy and ...

What is the current status of trial NCT00003582?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 1988-05. Estimated completion is 1996-12.

What conditions does trial NCT00003582 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Carcinoma of Unknown Primary.

What interventions are being tested in trial NCT00003582?

The interventions under investigation include: cisplatin (DRUG), paclitaxel (DRUG), quality-of-life assessment (PROCEDURE), fluorouracil (DRUG), amifostine trihydrate (DRUG).

Who is sponsoring clinical trial NCT00003582?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00003582 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Head and Neck Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00003582's enrollment target sits among peer trials

36 163rd of 250 higher than 87 of 250 other Head and Neck Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Cancer 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 NCT00003582, the US trial registry maintained by the National Library of Medicine. NCT00003582 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.