Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- 3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
研究概览
简要总结
The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.
详细描述
This is a phase II prospective study that will be accruing patients with post operative cervical or endometrial cancer requiring adjuvant pelvic radiation.
External beam radiotherapy (Intensity modulated radiotherapy/arc technique) will be delivered to pelvis to a dose of 39 Gray (Gy) in 13 fractions at 3 Gy per fraction, delivered once daily over 2.5 - 3 weeks. Treatment will be delivered with Intensity Modulated Radiotherapy (IMRT) under image guidance. Patients for whom concurrent chemotherapy is indicated (as per adverse risk features) will receive concurrent weekly cisplatin (40mg/m2) based on standard institutional protocol. All patients with post-operative cervical cancer will receive vaginal brachytherapy after the completion of external beam radiation. Patients with endometrial cancer with certain pre defined risk factors will also receive vaginal brachytherapy. The dose of vaginal brachytherapy will be 6 Gy high dose rate brachytherapy delivered as two different fractions, one week apart. Patients will be evaluated by the concerned investigators on a weekly basis during radiation therapy and all the toxicities will be documented according to the CTCAE V 5.0.
Patients will be followed up 3 monthly for the first 2 years, then 6 monthly from years 2 - 5, and annually thereafter. CTCAE version 5 will be used for toxicity grading at each follow-up. Quality of life assessment will be performed at baseline prior to the start of radiation and on follow-up at pre-specified times using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Cervix - 24 (CX24) for cervical cancer patients and Endometrium 24 (EN24) for endometrial cancer patients.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.
排除标准
- •Patients with macroscopic residual disease (R+ resection) postoperatively
- •Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)
- •Patients treated with chemotherapy for any prior malignancy at any time
- •Patients treated with pelvic radiation previously
- •Patients with human immunodeficiency virus infection
- •Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)
研究组 & 干预措施
Hypofractionated Image guided External Beam Radiation
Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
干预措施: Hypofractionated Image guided External Beam Radiation Therapy (EBRT) (Radiation)
Hypofractionated Image guided External Beam Radiation
Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
干预措施: Cisplatin (Drug)
Hypofractionated Image guided External Beam Radiation
Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
干预措施: Vaginal brachytherapy (Radiation)
结局指标
主要结局
3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
时间窗: Median follow up of 3 years
To evaluate the 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring receiving radiation with hypo fractionation.
次要结局
- Pelvic Control Rate at 3 years(Median follow up of 3 years)
- Assessment of Quality of Life for cervical cancer patients(Median follow up of 3 years)
- Acute Toxicities Evaluation(3 months)
- C-MOSES scoring(Median follow up of 3 years)
- Disease Free Survival at 3 years(Median follow up of 3 years)
- Overall Survival at 3 years(Median follow up of 3 years)
- Assessment of Quality of Life for endometrial cancer patients(Median follow up of 3 years)
研究者
Prachi Mittal, MD, Radiation Oncology
Assistant Professor
Tata Memorial Centre