Overview

This trial is active, not recruiting.

Condition prosthesis survival
Treatments radiotherapy, cisplatin, cisplatin and doxorubicin and cyclophosphamide, paclitaxel and carboplatin
Phase phase 2
Sponsor Fan Ming
Start date January 2008
End date January 2014
Trial size 80 participants
Trial identifier NCT01918124, 070148-7

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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) chemotherapy 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.

Primary Outcomes

Measure
Disease Free Survival(DFS)
time frame: From date of randomization until the date of first documented progression, assedded up to 60 months

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: From date of randomization until the date of death from any cause, assedded up to 60 months.

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Fudan University.