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Sparing of Organs at Risk in High Dose Rate Brachytherapy

2013年7月24日 更新者:Centre Oscar Lambret

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

完全的

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

观察性的

注册 (实际的)

24

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lille、法国、59020
        • Centre Oscar Lambret

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
At 8 weeks of external radiotherapy

次要结果测量

结果测量
措施说明
大体时间
Evaluation of medical imaging with CT-Scan and RMN for cervix cancer
大体时间:At 8 weeks of external radiotherapy
  • Interest of RMN sequences Water and T2 for the definition of volumes
  • Evaluation of imaging registration on the planning treatment system based on the brachytherapy applicator for the precision of volumes delineation
  • Evaluate the interest of TDM and RMN for volumes delineation
At 8 weeks of external radiotherapy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Philippe Nickers, MD, PhD、Centre Oscar Lambret

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年6月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2012年9月5日

首先提交符合 QC 标准的

2012年9月5日

首次发布 (估计)

2012年9月7日

研究记录更新

最后更新发布 (估计)

2013年7月25日

上次提交的符合 QC 标准的更新

2013年7月24日

最后验证

2013年7月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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