PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 试验地点
- 2
- 主要终点
- Vaginal relapse
研究概览
简要总结
RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.
PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.
详细描述
OBJECTIVES:
- Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.
- Compare 5-year rate of distant metastases in these patients.
- Determine overall survival rate in these patients.
- Determine prognostic factors for relapse and morbidity.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
- Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:
- •Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion
- •Age ≥60, stage IB grade 2 or 3 (with < 50% myometrial invasion)
- •Stage IIA, any age
- •No grade 3 endometrial carcinoma with deep myometrial invasion
- •Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation
- •WHO performance status 0-2
排除标准
- •Serous or clear cell histology or uterine sarcoma
- •staging lymphadenectomy
- •interval between surgery and radiotherapy > 8 weeks
- •history of previous malignant disease (except basal cell carcinoma of skin)
- •previous radiotherapy, hormonal therapy or chemotherapy
- •diagnosis of Chrohn's disease or ulcerative colitis
结局指标
主要结局
Vaginal relapse
时间窗: 5 years
total vaginal relapse and vaginal relapse as first failure
次要结局
- Rate of distant metastases(5 years)
- Overall survival(5 years)
- Adverse effects(5 years)
- Health-related quality of life(5 years)
- Pelvic relapse(5 years)
研究者
Carien Creutzberg
Professor of Radiation Oncology, Chief investigator
Leiden University Medical Center