PROTONS-RPS: a Phase II Non-Randomized Open-label Single-arm Trial Of Neoadjuvant Short-course Hypofractionated Proton Beam Therapy for Non-metastatic RetroPeritoneal Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection
研究概览
简要总结
The investigators' study titled "PROTONS-RPS: a Phase II non-Randomized Open-label single-arm Trial Of Neoadjuvant Short-course hypofractionated proton beam therapy for non-metastatic RetroPeritoneal Sarcoma" is a phase II trial evaluating the safety and efficacy of hypofractionated proton beam therapy (H-PBT) in the neoadjuvant (NA) setting for patients with non-metastatic retroperitoneal sarcoma (RPS) planned for surgical resection. This trial will include adult patients with resectable RPS.
详细描述
The investigators' primary outcome is overall complication rate after treatment with NA H-PBT and surgical resection based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.2 Secondary objectives include evaluating the acute toxicity of H-PBT prior to surgical resection, rate of progression between diagnosis and definitive resection, early post-operative complication rate after resection of RPS in patients who received NA H-PBT, and local recurrence-free survival at 1 and 2 years. A priori subset analyses will be conducted for patients with well-differentiated and dedifferentiated liposarcoma.
The investigators plan to accrue a minimum of 44 patients to evaluate the investigators' primary outcome. Treatment will be 5 doses of H-PBT including a simultaneous integrated boost to at-risk margins followed by surgical resection after 4-6 weeks. Patients will be followed in the post-operative setting according to standard of care surveillance for RPS.
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
- •Adult patients (≥18 years of age)
- •Patients with primary non-recurrent retroperitoneal sarcoma
- •Calculated creatinine clearance ≥50 mL/min and functional contralateral kidney based on nuclear medicine renal scan
- •Normal bone marrow function (WBC ≥ 4 x109 /L)
- •Eastern Cooperative Oncology Group status ≤ 2
- •Cardiac function ≤ New York Heart Association class II
- •Proton beam therapy approved by insurance (including Medicare/Medicaid)
排除标准
- •Evidence of metastatic disease on staging CT of chest/abdomen/pelvis
- •History of abdominal or pelvic radiation therapy
- •Inability to tolerate supine position for duration of PBT simulation or treatment
- •Tumor originating from gastrointestinal or gynecologic organs
- •Specific sarcoma histologies including osteosarcoma, desmoid tumors, chondrosarcoma arising from vertebrae or pelvic bones, embryonal rhabdomyosarcoma
- •Tumor extending into femoral or obturator canal
- •History of systemic lupus erythematosus or ulcerative colitis
- •Genetic syndrome with radiation-associated tumorigenicity (i.e.: Li-Fraumeni)
- •Presence of clinically significant ascites
- •Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
结局指标
主要结局
Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection
时间窗: 24 months
Incidence of acute Grade 3+ adverse events after PBT and surgical resection during median follow-up based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Rate of acute post-operative surgical complications in patients receiving NA short-course hypofractionated PBT(30 days after surgery)
- Local recurrence-free survival (LRFS)(Every 6 months, Up to 2 years)
- Tolerability of NA short-course hypofractionated PBT for primary resectable RPS as assessed by cessation of NA H-PBT due to toxicity or required dose reduction for serious adverse events(Up to 6 weeks)
- Rate of local or distant tumor progression from diagnosis to time of surgery after treatment with PBT(Up to 6 weeks (pre-operatively))
- Safety of NA short-course hypofractionated PBT for primary resectable RPS as assessed by incidence of acute Grade 3+ adverse events(Up to 6 weeks)