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
- 2
- 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.
研究组 & 干预措施
Hypofractionated Proton Beam Therapy
5 fractions of 5 Gy of PBT to clinical tumor volume +/- an additional simultaneous 1 Gy per fraction to any pre-determined at-risk margin (for a total of 6 Gy per fraction x 5 fractions for at-risk margins as a simultaneous integrated boost (SIB)).
干预措施: Hypofractionated Proton Beam Therapy (Radiation)
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)