A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- Korean Gynecologic Oncology Group
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Two year progression free survival
- Last Updated
- 19 years ago
Overview
Brief Summary
The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.
Detailed Description
Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection
- •Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV.
- •Patients must have a GOG performance of 0, 1, or
- •Patients must have expected life span over 6 months.
Exclusion Criteria
- •Patients with peripheral neurotoxicity over grade 2 in CTC criteria.
- •Patients with history of chemotherapy or radiation treatment.
- •patients with history of arrhythmia,congestive heart failure.
- •Patients with intractable infection.
Outcomes
Primary Outcomes
Two year progression free survival
Secondary Outcomes
- toxicity profile