A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Prosthesis Survival |
| Intervention | Radiation: radiotherapy Drug: Cisplatin Drug: Cisplatin and Doxorubicin and Cyclophosphamide Drug: Paclitaxel and Carboplatin |
| Phase | Phase 2 |
| Sponsor | Fan Ming |
| Responsible Party | Fudan University |
| ClinicalTrials.gov Identifier | NCT01918124 |
| First Received | July 29, 2013 |
| Last Updated | August 6, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 29, 2013 |
|---|---|
| Last Updated Date | August 6, 2013 |
| Start Date | January 2008 |
| Estimated Primary Completion Date | January 2014 |
| Current Primary Outcome Measures | Disease Free Survival(DFS) [Time Frame: From date of randomization until the date of first documented progression, assedded up to 60 months] [Designated as safety issue: No]From date of randomization until the date of first documented progression, assessed up to 60 months. |
| Current Secondary Outcome Measures | Overall Survival (OS) [Time Frame: From date of randomization until the date of death from any cause, assedded up to 60 months.] [Designated as safety issue: No]From date of randomization until the date of death from any cause, assessed up to 60 months. |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer |
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| 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 |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Prosthesis Survival |
| Intervention | Radiation: 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. Drug: Cisplatin Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy. Drug: 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. Drug: Paclitaxel and Carboplatin Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy. |
| Study Arm (s) | Experimental: radiotherapy combined with chemotherapy 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 80 |
| Estimated Completion Date | January 2014 |
| Estimated Primary Completion Date | January 2014 |
| Eligibility Criteria | 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01918124 |
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| Other Study ID Numbers | 070148-7 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Fudan University |
| Study Sponsor | Fan Ming |
| Collaborators | Not Provided |
| Investigators | Study Chair: Huaying Wang, Doctor Shanghai Cancer Center |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| Shanghai Cancer Center | Shanghai, Shanghai, China, 200000 |
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