A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- Peking University People's Hospital
- Enrollment
- 654
- Locations
- 1
- Primary Endpoint
- Progress-free survival
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients of primary treatment
- •All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
- •Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
- •All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.
- •Entry into the study is limited to no more than 8 weeks from the date of surgery.
- •Patients with adequate organ function, reflected by the following parameters:
- •WBC ≥ Normal value of the institution;
- •Absolute neutrophil count (ANC) ≥ Normal value of the institution;
- •Platelet count ≥ 100,000/mcl;
- •SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
Exclusion Criteria
- •Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
- •Patients with residual tumor after surgery.
- •Patients with other invasive malignancies.
- •Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy.
- •Patients with an estimated survival of less than 6 months.
- •Those who are unable or unwilling to comply with the research requirements
Outcomes
Primary Outcomes
Progress-free survival
Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months
To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of recurrence or death (i.e., increases disease-free survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.
Secondary Outcomes
- Overall survival(From the date of randomization until the date of death from any cause, assessed up to 60 months)
- adverse effect(through study completion,an average of 1 year)
- patient-reported Quality of Life(3 months after treatment and 1 year after treatment)