A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer

Study Overview
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Brief Summary
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This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.

Official Title
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A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer

Conditions
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Prosthesis Survival

Intervention / Treatment
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* Radiation: radiotherapy
* Drug: Cisplatin
* Drug: Cisplatin and Doxorubicin and Cyclophosphamide
* Drug: Paclitaxel and Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy. Additional surgical staging procedures are permissible but not required. Risk factors: patients must fit one of the following: Pelvic lymph node metastases Paraaortic lymph node metastases Grade 3 with myometrial invasion >50% With stromal invasion of cervix Known extrauterine disease (excluding second primary) confined to the pelvis. High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma, No known gross residual disease, or distant metastases. Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18 75. White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl. Acceptable hepatic and renal function: creatinine <=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) <=2*normal. No medical contraindications to chemotherapy, or radiation therapy. Study-specific signed informed consent. Exclusion Criteria: Prior pelvic radiation therapy. Positive peritoneal cytology only for stage IIIa (FIGO 1998). With history of other malignancies less than 5 years. With gross residual disease, or distant metastases. With endometrioid endometrial carcinoma and no risk factors: with myometrial invasion <50% Grade 1 2, with myometrial invasion >50% With serious internal diseases which affect designed treatment With psychotic disorders

Ages Eligible for Study
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Minimum Age: 18 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: radiotherapy combined with chemotherapy<br>Arm Label: radiotherapy combined with chemotherapy: Radiotherapy: Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery. Cisplatin: Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy. Cisplatin and Doxorubicin and Cyclophosphamide： Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) given at 3 week intervals following completion of radiotherapy. Paclitaxel and Carboplatin： Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy. | Radiation: radiotherapy<br>* Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.<br>Drug: Cisplatin<br>* Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.<br>Drug: Cisplatin and Doxorubicin and Cyclophosphamide<br>* Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.<br>Drug: Paclitaxel and Carboplatin<br>* Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival(DFS) | From date of randomization until the date of first documented progression, assessed up to 60 months. | From date of randomization until the date of first documented progression, assedded up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | From date of randomization until the date of death from any cause, assessed up to 60 months. | From date of randomization until the date of death from any cause, assedded up to 60 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disease free survival, overall survival