Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer
Phase 2
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT01461746
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 67
Inclusion Criteria
- One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of [Grade III, LVSI+, Mm>1/2] Clear cell or serous carcinoma: stage IB-II
- Age: 20-75
- ECOG PS: 0-2
- Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine <1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
- Informed Consent
Exclusion Criteria
- Previous chemotherapy or pelvic RT
- Hormone therapy within 4 weeks
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
- Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- Neurosis or psychosis
- Etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherpay and radiation therapy Docetaxel Docetaxel plus cisplatin followed by radiation therapy Chemotherpay and radiation therapy Radiation therapy Docetaxel plus cisplatin followed by radiation therapy Chemotherpay and radiation therapy Cisplatin Docetaxel plus cisplatin followed by radiation therapy
- Primary Outcome Measures
Name Time Method Progression-free survival 2 years after completion of study treatment
- Secondary Outcome Measures
Name Time Method Overall survival 2 years after completion of study treatment Quality of life 3 months after completion of study treatment Number of Participants with Adverse Events as a Measure of Safety and Tolerability Before each chemotherapy, an expected average of 3 weeks
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of