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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: Completed Phase 1 study of Cervical Cancer and Radiation Toxicity, sponsored by Radiation Therapy Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2001-08 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00012012 record still lists
NCT00012012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (92% lower).
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 lists 17 locations in 6 states (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.
Learn More About Clinical Trials
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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 NCT00012012's enrollment target sits among peer trials
45 104th of 144 higher than 41 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical 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.
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