Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Soft Tissue Sarcoma of Members

Intervention / Treatment
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* Radiation: Radiotherapy
* Other: absence of radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absence of Radiotherapy<br>No Radiotherapy; Simple monitoring without active treatment | Other: absence of radiotherapy<br>* absence of radiotherapy<br>* Other names: Observation;|
| Active Comparator: Radiotherapy<br>Radiotherapy | Radiation: Radiotherapy<br>* 50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the quality of life by questionnaire of quality of life QLCQ30 |  | 2021 | 
| Evaluation of acute and late complications |  | 2009 to 2021 | 
| Overall Survival |  | 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcoma, soft tissue, members, radiotherapy, absence of radiotherapy