MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer (MASTEC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 61
- 主要终点
- Acute gastrointestinal and genitourinary toxicity (within 3 months after start of treatment)
研究概览
简要总结
Rationale: External beam radiotherapy (EBRT) is an important cornerstone in treatment to reduce locoregional relapse in high(-intermediate) risk endometrial cancer (EC) patients. MR-guided adaptive radiotherapy (MGART) allows for more accurate delivery of radiation beams to the patients by visualizing and correcting for interfraction motion, with subsequent reduction of safety margins around the radiotherapy plan. Objective: The MASTEC study will investigate the safety of hypofractionated MR-guided adaptive radiotherapy in five fractions for elective pelvic nodal and vaginal vault irradiation in endometrial cancer.
Study design: Phase II multicentre intervention study Study population: Patients with endometrial cancer that receive adjuvant EBRT to the pelvic nodal areas and vaginal vault (with or without vaginal brachytherapy).
Intervention (if applicable): MR-guided adaptive radiotherapy (MGART) with reduced PTV margins, including 5 times 6Gy to the vaginal vault and pelvic nodal areas, 2 times a week .
Main study parameters/endpoints: The primary endpoint is acute gastrointestinal and genitourinary toxicity, scored by the Common Terminology Criteria Adverse Events version 6.0. Secondary endpoints are late gastrointestinal and genitourinary toxicity, quality of life and disease free survival; disease-specific survival; overall survival and metastasis-free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- •Women aged 18 years or older with histologically proven carcinoma of the endometrium, treated with curative hysterectomy with or without bilateral salpingo-oophorectomy. All histologies may be included (endometrioid, clear cell carcinoma, de-/undifferentiated carcinoma, carcinosarcoma, other non-endometrioid)
- •Candidate for adjuvant EBRT as decided by multidisciplinary tumour board, amongst others:
- •FIGO IB grade 3 endometrioid carcinoma
- •FIGO stage II endometrioid carcinoma
- •FIGO stage IIIA-C1 endometrioid carcinoma
- •FIGO IB-II clear cell carcinoma
- •FIGO IA-III carcinosarcioma
- •Patients receiving adjuvant systemic therapy are eligible when these therapies will not be administered concurrently
- •Patients receiving vaginal vault brachytherapy are eligible
- •Capable of giving informed consent
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •Contra-indications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrofobia
- •Presence of para-aortic lymph node metastases (FIGO stage IIIC2)
- •Prior pelvic radiotherapy
- •WHO performance score > 2
研究组 & 干预措施
Interventional arm
MR-guided stereotactic adaptive radiotherapy
干预措施: MR-guided adaptive radiotherapy (MGART) with reduced PTV margins, including 5 times 6Gy to the vaginal vault and pelvic nodal areas, 2 times a week (Radiation)
结局指标
主要结局
Acute gastrointestinal and genitourinary toxicity (within 3 months after start of treatment)
时间窗: 5 years after end of treatment
1. Primary outcomes: Acute gastrointestinal toxicity: Maximum CTCAE v6.0 grade of GI toxicity within 90 days after treatment. Acute genitourinary toxicity: Maximum CTCAE v6.0 grade of GU toxicity within 90 days after treatment. 2. Secondary Outcomes Late gastrointestinal toxicity: Maximum CTCAE v6.0 grade between 90 days and 5 years after treatment. Late genitourinary toxicity: Maximum CTCAE v6.0 grade between 90 days and 5 years after treatment. Acute vaginal toxicity: Maximum CTCAE v6.0 grade within 90 days after treatment. Late vaginal toxicity: Maximum CTCAE v6.0 grade between 90 days and 5 years after treatment. Quality of life: EORTC QLQ-C30 and QLQ-EN24 scores at 6 months and annually up to 5 years. Locoregional disease-free survival: Time to locoregional recurrence or death. Distant disease-free survival: Time to distant metastasis or death. Overall survival: Time to death from any cause. Endometrial cancer-specific survival: Time to death due to endometrial cancer
次要结局
未报告次要终点