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NCT01101451 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
A Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, sponsored by GOG Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT01101451 is a Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma that has completed, run by GOG Foundation. The registered enrollment target is 340 participants, above the 98-participant average among 13 other Cervical Adenocarcinoma trials with a reported enrollment target (247% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT01101451, a Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, has completed, sponsored by GOG Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
Conditions Studied
Interventions
- DRUG Cisplatin
- OTHER Quality-of-Life Assessment
- RADIATION External Beam Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mills-Peninsula Medical Center - Burlingame
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Saint Joseph's Hospital and Medical Center - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2010-04-12 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101451
The ClinicalTrials.gov registry entry for NCT01101451 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 98-participant average among 13 other Cervical Adenocarcinoma trials with a reported enrollment target (247% higher). The listed sponsor is GOG Foundation, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Cervical Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT01101451 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01101451 about?
NCT01101451 is a clinical study titled "Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery". This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used ...
What is the current status of trial NCT01101451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2010-04-12. Estimated completion is 2024-04-02.
What conditions does trial NCT01101451 study?
This clinical trial studies the following conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IIA Cervical Cancer AJCC v7, Stage I Cervical Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT01101451?
The interventions under investigation include: Cisplatin (DRUG), Quality-of-Life Assessment (OTHER), External Beam Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01101451?
This trial is sponsored by GOG Foundation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01101451 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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