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.
- 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
- 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
- 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