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Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer
NCT00003582 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 1988-05 |
| Est. Completion | 1996-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00003582
The ClinicalTrials.gov registry entry for NCT00003582 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00003582 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00003582?
This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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