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NCT00980954 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
NCT00980954: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00980954 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 236 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980954, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 236 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Primary Outcome
Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.
Interventions
- DRUG cisplatin
- DRUG carboplatin
- DRUG paclitaxel
- RADIATION intensity-modulated radiation therapy
- RADIATION standard external beam radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2009-09 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 3 |
What the finished NCT00980954 record still lists
NCT00980954 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00980954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00980954 about?
NCT00980954 is a clinical study titled "Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy". RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether c...
What is the current status of trial NCT00980954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2009-09. Estimated completion is 2025-09-04.
What interventions are being tested in trial NCT00980954?
The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), paclitaxel (DRUG), intensity-modulated radiation therapy (RADIATION), standard external beam radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00980954?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00980954's enrollment target sits among peer trials
236 1294th of 2000 higher than 705 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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