A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel
- Conditions
- Endometrial Cancer
- Sponsor
- Asan Medical Center
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Last Updated
- 8 years ago
Overview
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.
Investigators
Joo-Hyun Nam
Professor
Asan Medical Center
Eligibility Criteria
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
Arms & Interventions
Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
Intervention: Docetaxel
Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
Intervention: Cisplatin
Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
Intervention: Radiation therapy
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 2 years after completion of study treatment
Secondary Outcomes
- 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)