Sparing of Organs at Risk in High Dose Rate Brachytherapy
Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.
In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.
The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.
This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.
研究概览
地位
详细说明
After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions.
A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.
During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Lille、法国、59020
- Centre Oscar Lambret
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II.
After realization of external radiation therapy done (60 Gy in IMRT)
描述
Inclusion Criteria:
- Cervix carcinoma stage Ib to IV (FIGO)
- OMS < 2
- Tomography by positron emission and/or chirurgical staging before the external radiotherapy
- RMN before the starting of treatment and at the end af external radiotherapy
- Patient information
- Validation of the indication af high dose rate brachytherapy
- External radiation therapy (60 Gy with IMRT)
Exclusion Criteria:
- No external radiation therapy
- Surgery in the 4 weeks before before the inclusion
- Prior pelvic radiation therapy
- intestinal inflammatory disease or active pathology
- active infection or severe pathology didn't allow the treatment
- Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)
- Inclusion in another clinical trial
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification
大体时间:At 8 weeks of external radiotherapy
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To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
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At 8 weeks of external radiotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Evaluation of medical imaging with CT-Scan and RMN for cervix cancer
大体时间:At 8 weeks of external radiotherapy
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At 8 weeks of external radiotherapy
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合作者和调查者
调查人员
- 研究主任:Philippe Nickers, MD, PhD、Centre Oscar Lambret
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BRACHY-HDR
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