Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Side effects from radiation therapy
研究概览
简要总结
To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)
详细描述
To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)
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
- •Participants must have a histologically confirmed STS of the retroperitoneal space or infra-peritoneal spaces of pelvis
- •Participant must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT or MRI
- •Participant must have primary, locally recurrent, or metastatic disease requiring treatment of the retroperitoneal mass
- •Tumor must be suitable for radiotherapy and surgery based on pre-treatment CT scan/MRI in multidisciplinary discussion with surgeon and radiation oncologist (anticipated macroscopically complete resection, R0/R1 resection)
- •Age: 18 years or older
- •ECOG performance status ≤2
- •Absence of history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease.
- •Normal renal function (calculated creatinine clearance ≥50 mL/min)
- •Normal bone marrow and hepatic function (white blood cell count ≥2·5 × 10⁹ cells per L, platelet count ≥80 × 10⁹ cells per L, and total bilirubin <2 times upper limit of normal)
- •Women of child-bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
- •Patients capable of childbearing/reproductive potential should use adequate contraception
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Sarcoma originating from bone structure, abdominal or gynecological viscera
- •Any of the following histological subtypes: gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor or other small round blue cell sarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid or metastatic carcinoma
- •Prior RT to the RPS
- •Prior abdominal or pelvic irradiation for other prior malignancy or other disease
- •Prior different invasive malignancy may be eligible per the discretion of the treating investigator and review by the Principal Investigator (PI)
- •Prior chemotherapy or immunotherapy within 6 weeks of start of RT
- •Pregnant women are excluded from this study because RT has the potential for teratogenic or abortifacient effects.
- •HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for increased sensitivity to RT
研究组 & 干预措施
Hypofractionated Radiation Therapy
This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy)
干预措施: Radiation Therapy (Radiation)
Hypofractionated Radiation Therapy
This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy)
干预措施: Hypofractionationed Radiation Therapy (Radiation)
结局指标
主要结局
Side effects from radiation therapy
时间窗: From enrollment to 30-days after the completion of radiation treatment
Evaluation of acute radiation-related toxicity profile of each participant, specifically nausea, vomiting, diarrhea, and other gastrointestinal (GI) side effects.
次要结局
未报告次要终点
研究者
Miranda Lam, MD
Radiation Oncologist
Brigham and Women's Hospital