Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherpay and radiation therapy<br>Docetaxel plus cisplatin followed by radiation therapy | Drug: Docetaxel<br>* Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles<br>Drug: Cisplatin<br>* Cisplatin 60mg/m2BSA, q 3 weeks, 3 cycles<br>Radiation: Radiation therapy<br>* Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 years after completion of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall 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 |