IMRT Followed by CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume (Boost_Pelvis)
2022年6月20日 更新者：Centre Francois Baclesse, Luxembourg
Intensity Modulated Radiation Treatments Followed by A Stereotactic CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
The present register has been designed to confirm the hypothesis that while using high quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy could not be proposed as a boost.
研究概览
详细说明
This register concerned patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated.
- Placement of fiducials First of all, fiducials will be placed near or inside the Gross Tumor Volume (GTV).
- Radiation treatment The radiation treatment will be delivered by Varian Rapid ARC accelerators. 50 Gy will be delivered in the Planning Tumor Volume (PTV) 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
- CK Boost pelvis In the following 14 days after the external beam treatment, two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the organs at risk (OAR). This boost will be planned according to a recent paper, using a new CT scan and MRI scan for planimetric purposes. 95% of the prescribed dose will have to cover at least 90% of the PTV. The maximal CyberKnife tolerated doses to the OAR for a 6.5 Gy dose will be 5 Gy to 2cc of the bladder, rectum or sigmoid structures and 2.5 Gy to 5 cc of the small bowel. The protocol will not require a dose summation of the different steps of the treatment. The total duration of the whole treatment will have to be inferior to 55 days.
4 Follow-up The clinical follow up will be planed weekly during the radiation treatments, and at 2, 4 and 6 months thereafter. The patients will be then followed up every 4 months during the first 2 years and twice yearly thereafter.
A medical imaging using PET Scanner and MRI when possible will be performed at least at 6 months intervals during the first 2 years.
研究类型
观察性的
注册 (预期的)
120
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
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SUD
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Esch-sur-Alzette、SUD、卢森堡、L-4240
- Centre François Baclesse
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated
描述
Inclusion Criteria:
- any kind of locally advanced pelvic tumor, non-operable for any reason
- signed informed consent
- concomitant chemotherapy or hormonotherapy unless gemcitabine will not be contraindicated during the treatment
Exclusion Criteria:
- possibility to easily offer the patient a brachytherapy boost
- extra pelvic tumor dissemination above the L3 vertebra
- collagenoses
- any bowel tumor when the digestive tract is not definitely and locally bypassed
- any biologic targeted therapy or anti angiogenic therapy within the 6 weeks preceding the initiation of the radiation treatment, for the first 20 patients. This point will be revisited afterwards and will conduct to an amendment in case of protocol modification
- gemcitabine chemotherapy within the 6 weeks preceding the initiation of the radiation treatment or during the treatment
- hip prostheses
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
队列和干预
团体/队列 |
干预/治疗 |
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CK Boost pelvis
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50 Gy will be delivered in the PTV 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days.
Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
Two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the OAR
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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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Severe toxicity
大体时间：follow up during 3 years after patient inclusion
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The objective is to confirm an expected toxicity level of severe toxicity < 5%
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follow up during 3 years after patient inclusion
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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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Local clinical control rates
大体时间：follow up during 3 years after patient inclusion
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Ths objective is to study the local control rates defined by a study panel board including at least a radiologist specially trained to review the imaging data after high radiation doses per fraction and the coordinator of the register, using PET Scanner, MRI and clinical data
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follow up during 3 years after patient inclusion
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Extra pelvic dissemination rates
大体时间：follow up during 3 years after patient inclusion
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The objective is to study the dissemination data of the disease above the pelvis
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follow up during 3 years after patient inclusion
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Ability of the multi leaf collimator to better cover the PTVs and to help shortening the delivery times
大体时间：follow up during 3 years after patient inclusion
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Using the different Conformal Index modalities, the objective is to compare the treatment planning with or without using the multi leaf collimator
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follow up during 3 years after patient inclusion
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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。
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 (实际的)
2017年5月31日
初级完成 (预期的)
2023年12月31日
研究完成 (预期的)
2023年12月31日
研究注册日期
首次提交
2017年6月30日
首先提交符合 QC 标准的
2017年6月30日
首次发布 (实际的)
2017年7月2日
研究记录更新
最后更新发布 (实际的)
2022年6月22日
上次提交的符合 QC 标准的更新
2022年6月20日
最后验证
2022年6月1日
更多信息
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.
Radiation treatment的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中