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Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix
NCT00003078 · 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. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known whether receiving radiation therapy plus cisplatin is more effective than receiving radiation therapy plus fluorouracil in treating patients with cancer of the cervix. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage IVA cancer of the cervix.
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG fluorouracil
- RADIATION radiation therapy
- RADIATION brachytherapy
Study Locations (20)
California
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA — Los Angeles
- Chao Family Comprehensive Cancer Center — Orange
- Women's Cancer Center — Palo Alto
Illinois
- Rush-Presbyterian-St. Luke's Medical Center — Chicago
- University of Chicago Cancer Research Center — Chicago
- CCOP - Central Illinois — Decatur
- CCOP - Evanston — Evanston
District of Columbia
- Vincent T. Lombardi Cancer Research Center, Georgetown University — Washington D.C.
- Walter Reed Army Medical Center — Washington D.C.
Florida
- Fred J. Woods Radiation Therapy Center/St. Joseph's Cancer Institute — Tampa
- H. Lee Moffitt Cancer Center and Research Institute — Tampa
Alabama
- University of Alabama Comprehensive Cancer Center — Birmingham
Arizona
- CCOP - Greater Phoenix — Phoenix
Colorado
- University of Colorado Cancer Center — Denver
Georgia
- Emory University Hospital - Atlanta — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 1997-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00003078
The ClinicalTrials.gov registry entry for NCT00003078 describes a study currently listed as completed. It is categorized as Phase 3, 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 870 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gynecologic Oncology Group, which has 61 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 4 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: NCT00003078 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Illinois, District of Columbia. 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 NCT00003078 about?
NCT00003078 is a clinical study titled "Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix". 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 radiation therapy and chemotherapy may kill more tumor cells. It is not known whether receiving radiation...
What is the current status of trial NCT00003078?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 870 participants. The study started on 1997-10.
What conditions does trial NCT00003078 study?
This clinical trial studies the following conditions: Cervical Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00003078?
The interventions under investigation include: cisplatin (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION), brachytherapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00003078?
This trial is sponsored by Gynecologic Oncology Group, which has 61 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00003078 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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