Randomised Multicentric Phase III Study Comparing Observation Versus Post-surgery Radiotherapy After Complete Exeresis With Margins Greater Than or Equal to 1 cm in Soft Tissues Members Sarcoma.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 36
- 主要终点
- Evaluation of local control at 5 years after surgery compared with exclusive post-operative radiotherapy for soft tissue tumors of the members who have surgery with wide excision margins greater than or equal to 10 mm.
研究概览
简要总结
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.
These rare tumors involve complex multidisciplinary care better in centers having expertise.
Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.
The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.
The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.
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
- •Soft tissue sarcoma members histologically confirmed
- •Tumor primitive complete excision with margins greater than or equal to 10 mm in the soft tissue in all directions during the initial surgery.
- •A sub-centimeter margin is authorized under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 a margin sub-centimeter depth is allowed for superficial tumors if the underlying fascia RESECTED is not invaded.
- •Primitive tumors without breaking initial tumor and without tumor residue in the systematic recovery in case of incomplete initial excision margins or doubtful
- •WHO less than or equal to 2
- •Age greater than or equal to 18 years
- •Review extension negative (normal chest CT)
- •Information and monitoring possible
- •Patient affiliated to social security
排除标准
- •Previously treated local sarcoma relapse
- •Visceral or lymph node metastases
- •pre-operative treatment (chemotherapy or radiotherapy)
- •PNET, alveolar rhabdomyosarcoma, Darrier-Ferrand sarcoma
- •excision margins of less than 10 mm in one direction or doubtful or unspecified, except under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 and tumors if the superficial fascia underlying RESECTED is not invaded.
- •Break-tumor during the initial surgery, or residual tumor at second surgery
- •Chemotherapy
- •Delay between surgery R0 margins greater than or equal to 1 cm (initial surgery or recovery) and the start of radiotherapy exceeding 8 weeks
- •History of radiation on the Member
- •History of cancer (except carcinoma in situ of the cervix and basal cell skin cancer or in complete remission for over 5 years)
- •Pregnant Women
- •Patients under guardianship or curatorship
研究组 & 干预措施
Absence of Radiotherapy
No Radiotherapy; Simple monitoring without active treatment
干预措施: absence of radiotherapy (Other)
Radiotherapy
Radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Evaluation of local control at 5 years after surgery compared with exclusive post-operative radiotherapy for soft tissue tumors of the members who have surgery with wide excision margins greater than or equal to 10 mm.
时间窗: 2021
次要结局
- Evaluation of the quality of life by questionnaire of quality of life QLCQ30(2021)
- Overall Survival(2021)
- Evaluation of acute and late complications(2009 to 2021)