Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy With Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival and failure-free survival of patients with high-risk stage IB-III endometrial carcinoma treated with concurrent chemoradiotherapy followed by adjuvant chemotherapy vs pelvic radiotherapy alone.
Secondary
- Compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life of patients treated with these regimens.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:
- •stage IA with invasion, grade 3 with documented LVSI
- •stage IB grade 3
- •stage IIIA or IIIC; or IIIB if parametrial invasion only
- •stage IA (with invasion), IB, II, or III with serous or clear cell histology
- •WHO-performance status 0-2
- •WBC ≥ 3.0 x 109/L.
- •Platelets ≥ 100 x 109/L.
- •Bilirubin ≤ 1.5 x UNL
- •ASAT/ALAT ≤ 2.5 x UNL
- •Written informed consent
- •Exclusion criteria:
- •Uterine sarcoma (including carcinosarcoma)
- •Previous malignancy (except for non-melanomatous skin cancer) < 10 yrs
- •Previous pelvic radiotherapy
- •Hormonal therapy or chemotherapy for this tumor
- •Macroscopic stage II for which Wertheim type hysterectomy (eligible if stage II grade 3 or stage III at pathology)
- •Prior diagnosis of Crohn's disease or ulcerative colitis
- •Residual macroscopic tumor after surgery
- •Creatinine clearance ≤ 60 ml/min (Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance)
- •Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
- •Peripheral Neuropathy > or = grade 2
- •Hearing impairment > or = grade 3, or born deaf
排除标准
- 未提供
研究组 & 干预措施
Radiation Therapy
Pelvic Radiotherapy alone
干预措施: Radiation Therapy (Radiation)
Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
干预措施: Radiation Therapy (Radiation)
Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
干预措施: cisplatin (Drug)
Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
干预措施: carboplatin (Drug)
Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall survival
时间窗: 5 years
co-primary endpoint
Failure-free survival
时间窗: 5 years
co-primary endpoint
次要结局
- Quality of life by QLQ-C30 v3.0(5 years)
- Severe treatment-related morbidity(5 years)
- Vaginal or pelvic relapse(5 years)
- Distant metastases(5 years)
研究者
Carien Creutzberg
Chief Investigator
Leiden University