Radiotherapy Treatment Planning Comparison Using SBRT-PATHY (Photons) Versus CARBON-PATHY for Unresectable Bulky Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Phase A: optimization of contouring and planning using PATHY strategy
研究概览
简要总结
This study uses a novel unconventional radiotherapy technique, consisting of high dose PArtial Tumor irradiation targeting exclusively the HYpoxic segment of unresectable bulky tumors delivered either with photons (SBRT-PATHY) or with carbon-ions (CARBON-PATHY) while sparing the peritumoral immune microenvironment (PIM).
详细描述
This study will be conducted as a two phase study. Phase A is a retrospective study. Up to 10 patients with bulky (>6cm tumors) previous planned with planning CT with IV contrast will be selected for planning and dosimetry comparison. This is performed to optimize the contouring and planning procedures. Phase B is a prospective study. Ten patients with bulky (>6cm tumor) requiring radiotherapy, with planning CT and MR with IV contrast will be accrued. Every effort will be made to include equal numbers of patients (2-3) from head and neck, thorax, abdomen and pelvis. Their images will be used for planning and dosimetry comparison.
Patients will be treated according to clinical plans. The study plans will not be used for treatment. Treatment plans for Photon delivery (SBRT-PATHY) and Carbon delivery (CARBON-PATHY) to deliver 30 Gy in three fractions will be planned to be delivered to the BTV will be performed. SBRT-PATHY plans will be generated at the Princess Margaret Cancer Center (PMCC, Toronto, Canada) while CARBON-PATHY plans will be generated at the MedAustron Center for Particle Therapy and Research (W. Neustadt, Austria).
The objective is to compare the dosimetric profile achievable using SBRT-PATHY (using photons) and CARBON-PATHY (using carbon-ions) for unresectable bulky tumors and surrounding tissues.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (for use their planning CT and MR data for study specific planning)
- •Malignant solid bulky primary or recurrent tumor with diameter of ≥6 cm
- •Age > 18 years
- •Radiation planning CT (with IV contrast) and MRI (with or without IV contrast) is planned
排除标准
- •Patients without bulky lesions,
- •Contraindication to i.v. CT and MRT contrast medium administration, particularly estimated glomerular filtration rate (GFR) less than 45 mL/min/1.73 m².
- •Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control,
- •Any condition that, in the opinion of the investigators, would interfere with treatment planning or interpretation of study results
- •Note (1): criterion n°4 will be evaluated on the four eyes principle, evaluated by both Principle Investigator and Sub-Investigators.
结局指标
主要结局
Phase A: optimization of contouring and planning using PATHY strategy
时间窗: 18 months (phase A and B combined)
The objective of phase A is to optimize the target delineation, planning strategy and techniques for SBRT-PATHY at Princess Margaret and CARBON-PATHY at MedAustron.
Phase B: optimal coverage of Bystander tumor volume (BTV) while allowing the maximal radiation-sparing of PIM and regional lymph nodes
时间窗: 18 months (phase A and B combined)
a prospective identification of 10 patients who are recommended to receive radiotherapy fulfilling the inclusion criteria. SBRT-PATHY and CARBON-PATHY planning is perfomed for study purposes only. A planning comparison between SBRT-PATHY (using photons) and CARBON-PATHY (using carbon-ions) based on dosimetric consideration achieved for the targeted BTV, non-targeted surrounding NTV (normoxic tumor segment), PIM, regional metastases (i.e. local regional involved nodes and distant metastases located within 15 cm cranial caudal to GTV), regional uninvolved lymph nodes and surrounding organs at risk (OAR) will be performed.
次要结局
- Phase B: Dosimetric-sparing of Organs at risk (OAR) and regional nodes(18 months (phase A and B combined))
- Phase B: Dosimetric-sparing of normoxic tumor volume (NTV)(18 months (phase A and B combined))
- Phase B: Feasibility for dosimetric-sparing of regional/distant metastases as abscopal tumor sites (if present)(18 months (phase A and B combined))