Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
- Registration Number
- NCT01461759
- Lead Sponsor
- Asan Medical Center
- Brief Summary
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 59
Inclusion Criteria
- Histologically confirmed chemotherapy naïve endometrial cancer
- One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
- FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
- At least one measurable lesion by RECIST on CT
- ECOG PS: 0-2
- Age: 20-75
- Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
- Informed Consent
- Contraception during study period
Exclusion Criteria
- Previous chemotherapy
- RT, hormone therapy, or immunotherapy within 1 month
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
- Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- Neurosis or psychosis
- Pregnancy, breast-feeding
- Etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy Doctaxel Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles Chemotherapy Cisplatin Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
- Primary Outcome Measures
Name Time Method Response rate 3 months after completion of study treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival 2 years 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 Quality of life 3 months after completion of study treatment
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of