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NCT00012012 · ClinicalTrials.gov registry record · Phase 1

Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer

A Phase 1 study of Cervical Cancer and Radiation Toxicity, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target
17
Study locations

NCT00012012 is a Phase 1 study of Cervical Cancer and Radiation Toxicity that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 45 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (92% lower). The trial reports 17 study locations across 6 states.

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The verdict

NCT00012012, a Phase 1 study of Cervical Cancer and Radiation Toxicity, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target
17
Study locations

Study Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.

Interventions

  • DRUG Cisplatin
  • RADIATION External beam radiation therapy
  • DRUG Amifostine trihydrate
  • RADIATION Intracavitary brachytherapy

Study Locations (17)

Florida

  • Baptist Cancer Institute - Jacksonville - Jacksonville
  • Florida Oncology Associates at Southside Cancer Center - Jacksonville
  • Integrated Community Oncology Network - Jacksonville Beach
  • Baptist Medical Center South - Jascksonville
  • Florida Oncology Associates - Orange Park
  • Florida Cancer Center - Palatka - Palatka
  • Flagler Cancer Center - Saint Augustine

Michigan

  • West Michigan Cancer Center - Kalamazoo
  • Bronson Methodist Hospital - Kalamazoo
  • Borgess Medical Center - Kalamazooaa

Nevada

  • University Medical Center of Southern Nevada - Las Vegas
  • CCOP - Nevada Cancer Research Foundation - Las Vegas

New Jersey

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton - Marlton
  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare - Vineland

Ohio

  • Akron City Hospital - Akron
  • Cancer Treatment Center - Wooster

Pennsylvania

  • Mercy Cancer Institute at Mercy Hospital - Pittsburgh

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2001-08
Est. Completion 2010-06
Phase Phase 1

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00012012

The ClinicalTrials.gov registry entry for NCT00012012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.

NCT00012012 reports 17 study locations spanning 6 distinct geographic areas - top geographies include Florida, Michigan, Nevada.

Frequently Asked Questions

What is clinical trial NCT00012012 about?

NCT00012012 is a clinical study titled "Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer". RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifosti...

What is the current status of trial NCT00012012?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2001-08. Estimated completion is 2010-06.

What conditions does trial NCT00012012 study?

This clinical trial studies the following conditions: Cervical Cancer, Radiation Toxicity.

What interventions are being tested in trial NCT00012012?

The interventions under investigation include: Cisplatin (DRUG), External beam radiation therapy (RADIATION), Amifostine trihydrate (DRUG), Intracavitary brachytherapy (RADIATION).

Who is sponsoring clinical trial NCT00012012?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00012012 being conducted?

This trial has 17 study locations across Florida, Michigan, Nevada, New Jersey, Ohio. 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 Editorial

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.