A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 37
- 主要终点
- Number of Patients With Abdominal Recurrence or Death
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
详细描述
OBJECTIVES:
Primary
- To assess whether there is a difference in abdominal recurrence-free survival between retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery.
Secondary
- To assess whether there is a difference in metastasis-free survival, abdominal recurrence-free interval, and overall survival between these patients.
- To assess tumor response in patients undergoing preoperative radiotherapy.
- To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following:
- •Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
- •Sarcoma not originated from bone structure, abdominal, or gynecological viscera
- •Unifocal tumor (not multifocal disease)
- •Absence of extension through the sciatic notch or across the diaphragm
- •The following histological sub-types are not allowed:
- •Gastrointestinal stromal tumor (GIST)
- •Rhabdomyosarcomas
- •Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma
- •Osteosarcoma or chondrosarcoma
- •Aggressive fibromatosis
- •Sarcomatoid or metastatic carcinoma
- •No metastatic disease
- •Untreated disease
- •Tumor must be operable and suitable for radiotherapy, based on the following criteria:
- •Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection)
- •No surgery anticipated to be R2 on the CT scan before randomization
- •Must have American Society of Anesthesiologist (ASA) score ≤ 2
- •None of the following unresectable criteria:
- •Involvement of superior mesenteric artery
- •Involvement of aorta
- •Involvement of bone
- •Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast)
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •WBC ≥ 2,500/mm^3
- •Platelet count ≥ 80,000/mm^3
- •Total bilirubin < 1.5 times the upper limit normal
- •Calculated creatinine clearance normal
- •Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram
- •Adequate cardiac function (NYHA class I-II)
- •ECG normal (without clinically significant abnormalities)
- •No history of any of the following disorders:
- •Bowel obstruction
- •Mesenteric ischemia
- •Severe chronic inflammatory bowel disease
- •Negative pregnancy test
- •Not pregnant or nursing concurrently and for at least 1 month after the surgery
- •Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery
- •No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •PRIOR CONCURRENT THERAPY:
- •No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy
- •No prior abdominal or pelvic irradiation for another prior malignancy or other disease
- •No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy)
- •No postoperative radiotherapy planned
排除标准
- 未提供
研究组 & 干预措施
Preoperative radiotherapy followed by en-bloc surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
干预措施: therapeutic conventional surgery (Procedure)
Surgery alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
干预措施: therapeutic conventional surgery (Procedure)
Preoperative radiotherapy followed by en-bloc surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
干预措施: 3-dimensional conformal radiation therapy (Radiation)
结局指标
主要结局
Number of Patients With Abdominal Recurrence or Death
时间窗: ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.
Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
次要结局
- Acute Toxicity Profile of Preoperative Radiotherapy.(From date of randomization to the date of surgical procedure, prior to surgery)
- Perioperative Complications(From the date of surgery, up to 60 days following surgery)
- Late Complications(From day 60 after surgery till end of follow-up, up to 7 years)
- Tumor Response to Preoperative Radiotherapy(Two weeks after completion of Pre-operative Radiotherapy, before Surgery)
- Number of Patients With an Abdominal Recurrence(ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years)
- Number of Patients With Metastases or Death(Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.)
- Number of Patients Alive(Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 years)