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NCT00077051 · ClinicalTrials.gov registry record · Phase 1

Cytochlor and Tetrahydrouridine as Radiosensitizers and Cisplatin Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)

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

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

NCT00077051 is a Phase 1 study of Head and Neck Cancer that has completed, run by University of Miami. The registered enrollment target is 1 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00077051, a Phase 1 study of Head and Neck Cancer, has completed, sponsored by University of Miami.

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

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. 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. Combining radiosensitizers with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine, cisplatin and radiation therapy in treating patients with advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).

Conditions Studied

Interventions

  • DRUG cisplatin
  • RADIATION radiation therapy
  • DRUG cytochlor
  • DRUG tetrahydrouridine

Study Locations (1)

Florida

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2004-04
Est. Completion 2007-07
Phase Phase 1

Sponsor

University of Miami

721 total trials

What the Registry Record Tells You About NCT00077051

The ClinicalTrials.gov registry entry for NCT00077051 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (100% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which cisplatin is the first listed.

NCT00077051 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00077051 about?

NCT00077051 is a clinical study titled "Cytochlor and Tetrahydrouridine as Radiosensitizers and Cisplatin Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin work in different ways to stop the growth of tumor cell...

What is the current status of trial NCT00077051?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2004-04. Estimated completion is 2007-07.

What conditions does trial NCT00077051 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT00077051?

The interventions under investigation include: cisplatin (DRUG), radiation therapy (RADIATION), cytochlor (DRUG), tetrahydrouridine (DRUG).

Who is sponsoring clinical trial NCT00077051?

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

Where is trial NCT00077051 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.