HypofracTionated Radiotherapy In Soft Tissue Sarcomas of Extremities and Limb Girdles – A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 372
- 试验地点
- 1
研究概览
简要总结
This is a randomized, open-label, phase II trial comparing ultra-hypofractionated pre-operative radiotherapy (UH-NART) with standard fractionated pre-operative radiotherapy (SF-NART) in patients with soft tissue sarcoma of the extremities and limb girdles. A total of 372 patients will be randomized in a 1:1 ratio to receive either 25–30 Gy in 5 fractions (UH-NART) or 50 Gy in 25 fractions (SF-NART) prior to surgery.
The primary objective is to compare 3-year local recurrence-free survival (LRFS) between the two treatment arms. Secondary outcomes include major wound complications, acute and late toxicities, disease-free survival, overall survival, radiological and pathological response, functional outcomes, quality of life, and direct treatment-related expenditure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •greater than or equal to 18 years of age Karnofsky Performance Status KPS 70 or above Core needle biopsy obtained for pathologic confirmation of primary soft tissue sarcoma FNCLCC grading intermediate or high Site extremities and limb girdles (scapula and pelvis) Localised disease – primary or recurrent Size less than 30cm Prior inappropriate biopsy or unplanned surgery in single specimen which is planned for re-surgery as per clinical decision MR imaging of the primary tumour at diagnosis Medically and surgically operable documentation of resectability after appropriate evaluation by orthopaedic oncosurgeons Informed consent obtained prior to inclusion Patient willing and reliable for follow up and QOL.
排除标准
- •Locally advanced presence of lymph nodes and metastatic disease Prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
- •Pregnant women Round cell sarcoma histologies Patients with a synchronous primary cancer requiring treatment STS of headneck retroperitoneum or chestwall regions Tumor size greater than or equal to 30 cm in any plane Tumours requiring vascular reconstruction Patients with known immunosuppression HIV or history of longterm steroid intake or uncontrolled diabetes HbA1C greater than 7 Complete microscopic resection of tumour deemed unfeasible or doubtful Prior piece meal unplanned surgery Patients unfit for general anaesthesia medically inoperable Any contraindication to radiotherapy like DNA repair syndromes Unable to follow up or poor logistic or social support.
研究者
Dr Jifmi Jose Manjali
Tata Memorial Centre