Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2023-12-14
- Completion
- 2025-09-04
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm I: Cisplatin/Radiation Therapy vs Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel; p = 0.56 NCT00980954 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |