A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 59
- 主要终点
- Progression-free survival at 5 years
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.
PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of patients with primary soft tissue sarcoma of the retroperitoneum or pelvis treated with surgery with vs without preoperative radiotherapy.
Secondary
- Compare the toxicity and complications associated with these regimens in these patients.
- Compare the rate of microscopically complete surgical resection in patients treated with these regimens.
- Compare the overall survival rate of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa)
- •The following histologies are eligible:
- •Alveolar soft part sarcoma
- •Anaplastic sarcoma
- •Angiosarcoma
- •Atypical lipomatous tumor (low-grade liposarcoma)
- •Clear cell sarcoma
- •Epithelioid sarcoma
- •Fibrosarcoma
- •Leiomyosarcoma
- •Liposarcoma (all subtypes)
- •Malignant fibrous histiocytoma
- •Malignant peripheral nerve sheath tumor
- •Myxofibrosarcoma
- •Neurofibrosarcoma
- •Spindle cell sarcoma
- •Synovial sarcoma
- •Unclassified sarcoma
- •The following histologies are not eligible:
- •Rhabdomyosarcoma
- •Extraosseous Ewing's sarcoma
- •Primitive neuroectodermal tumor
- •Osteosarcoma
- •Chondrosarcoma
- •Aggressive fibromatosis (desmoid tumor)
- •Gastrointestinal stromal tumor
- •Sarcomatoid carcinoma
- •Hemangiopericytoma
- •Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that ≥ 90% of the tumor volume is located within the retroperitoneal space
- •No bowel obstruction OR history of previous bowel obstruction attributed to retroperitoneal tumor
- •Primary non-visceral retroperitoneal masses consistent with sarcoma allowed provided diagnoses of carcinoma, melanoma, and lymphoma are excluded by immunohistochemistry
- •Measurable gross disease by abdominopelvic CT scan (with IV and oral contrast) or MRI (with IV contrast)
- •Patients must have undergone radiotherapy consultation within the past 30 days to confirm the feasibility of preoperative external-beam radiotherapy
- •Patients must have undergone surgical consultation within the past 30 days to confirm and document the feasibility of macroscopically complete resection
- •No prior macroscopically incomplete (R2) resection (i.e., partial debulking or subtotal tumor resection with gross residual disease)
- •No pelvic sarcoma extending through the sciatic notch
- •No clinical or radiographic evidence of probable metastatic disease
- •Equivocal pulmonary or liver lesion allowed provided the likelihood of metastatic disease is small
- •No sarcoma arising from bone or any retroperitoneal viscus (except the kidney)
- •No sarcoma extending across the diaphragm into the thorax
- •No recurrent retroperitoneal tumor
- •No multifocal disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-1 OR
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- 另有 20 项未显示
排除标准
- 未提供
研究组 & 干预措施
surgery
Patients undergo surgery.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
干预措施: conventional surgery (Procedure)
radiation + surgery
Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
干预措施: conventional surgery (Procedure)
radiation + surgery
Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Progression-free survival at 5 years
时间窗: at 5 years
次要结局
未报告次要终点