Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 12
- 主要终点
- Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
研究概览
简要总结
This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Cervix carcinoma proved by histology
- •According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
- •Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
- •Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
- •Older than 18 years
- •Good general status, World Health Organization less or equal to 1
- •Signed informed consent
排除标准
- •History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
- •History of pelvic irradiation
- •Simultaneous participation to another research that could interfere with the study results
- •Pregnant or breastfeeding patient
- •Patient under tutor or guardian
- •Patient not able to respect medical follow-up for geographical, social or psychological reasons
- •Not affiliated to a system of French social security
研究组 & 干预措施
Adaptative Treatment plans
A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day.
干预措施: Adaptative treatment plan (Other)
Adaptative Treatment plans
A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day.
干预措施: External radiotherapy (Radiation)
结局指标
主要结局
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
时间窗: 3 months after end of radio-chemotherapy treatment
次要结局
- Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03(3 months after end of radio-chemotherapy treatment)