Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Assessment of Grade > 2 Late Pelvic Toxicities
研究概览
简要总结
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.
The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.
详细描述
Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference treatments for localized prostate cancer. Prostate was initially thought to be a non-moving target, but the newest reports have raised the contrary as evidence. Image-guided radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which enables to take into account interfractional prostate motion before treatment.
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.
As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ motion, margin reduction can reasonably be considered in case of target motion management improvement.
To date, no prospective randomized clinical data is available using this technique for the treatment of low- or intermediate-risk prostate cancer patients with modern standard fractionation radiotherapy and image guidance.
The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Localized prostate cancer, histologically proven.
- •No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral lymph node dissection is not mandatory if lymph node involvement risk is low according to the Partin tables).
- •Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2 and Gleason < 8 and PSA < 20 ng/ml) (appendix 3).
- •No grade > 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03 scale.
- •Performance status ECOG ≤
- •No hip prosthesis or metallic vascular graft near the prostate.
- •No endopenian stent.
- •No pace maker, implanted defibrillator or neurostimulator.
- •No allergy to local anesthetics.
- •No irreversible anticoagulation or antiplatelet treatment for the implantation period.
- •Pelvic and abdominal anatomy compatible with the use of the Calypso® system (predictive detector to fiducials distance less than 19 cm, evaluated on planning CT-scan) (distance from skin surface to prostate center less than 17 cm).
- •Patient aged ≥ 18 and less than 80 years old.
- •Dated and signed written informed consent available.
- •Patients must be affiliated to a French Social Security System.
排除标准
- •Indication of pelvic nodes irradiation.
- •Prior pelvic irradiation.
- •Biopsy-proven seminal vesicle invasion.
- •Prior bilateral orchiectomy.
- •Prior radical prostatectomy.
- •Other malignancy except adequately-treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease-free for at least 5 years.
- •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary embolism, etc.).
- •Known VIH positive patients (no specific test needed).
- •Known homozygote ATM Mutation (Ataxia telengiectasia).
研究组 & 干预措施
Image-guided radiation therapy (IGRT) with standard margins
moderate hypofractionation during 4 weeks
干预措施: moderate hypofractionation Radiotherapy (Radiation)
Calypso tracking system with margin reduction
moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
干预措施: Calypso beacon implant (Device)
Calypso tracking system with margin reduction
moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
干预措施: moderate hypofractionation Radiotherapy (Radiation)
结局指标
主要结局
Assessment of Grade > 2 Late Pelvic Toxicities
时间窗: between 3 months and 2 years after radiation period
assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period
次要结局
- Biological Relapse-free Survival(at 5 years after the radiotherapy)
- Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)(at 5 years after the radiotherapy)
- Overall Survival(from the baseline to 5 years after the radiotherapy)