Proton Radiotherapy for Retroperitoneal Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Acute toxicity as assessed by NCI CTC Version 3.0
研究概览
简要总结
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with retroperitoneal sarcoma. PURPOSE: This phase I trial is studying the side effects and and best dose of proton beam radiation therapy in treating patients with retroperitoneal sarcoma.
详细描述
Detailed DescriptionPRIMARY OBJECTIVES:
I. To determine the feasibility and toxicity of proton radiotherapy for retroperitoneal sarcomas.
II. To determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas.
III. To determine the maximally tolerated dose of proton radiotherapy for patients with potentially resectable retroperitoneal sarcoma. (Pre-operative cohort) IV. To assess acute side effects from irradiation using proton beam therapy and dose/volume constraints that are derived from conventional radiotherapy. (Postoperative cohort)
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with a histologic diagnosis of sarcoma in the peritoneum/retroperitoneum/pelvis are eligible for this study
- •Patients must have either radiographic(pre-operative) or pathologic (post-operative) evidence of disease limited the peritoneum/retroperitoneum/pelvis without evidence of peritoneal sarcomatosis
- •For pre-operative cases, the patient must be considered operable/resectable as judged by the attending surgeon (this is determined by an extensive radiographic and medical evaluation that includes but is not limited to: CT Chest and Abdomen with contrast, MRI/CT Brain and Medical/Cardiac Clearance)
- •Patients should have an EGOC status of 0-2
- •Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks (patients unwilling or unable to sign informed consent are excluded from the study)
- •Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
排除标准
- •Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- •Pregnant women, women planning to become pregnant and women that are nursing
- •Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease
结局指标
主要结局
Acute toxicity as assessed by NCI CTC Version 3.0
时间窗: Within 60 days of completion of radiotherapy
次要结局
- Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system(After 60 days of therapy)
- Clinical efficacy(One year)