Status:
TERMINATED
Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Soft Tissue Sarcoma of Members
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2017
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00870701
Start Date
March 19 2009
End Date
March 10 2017
Last Update
August 22 2018
Active Locations (18)
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1
Institut de Cancérologie de l'Ouest - Centre Paul Papin
Angers, France, 49933
2
Institut Bergonié
Bordeaux, France, 33076
3
Centre François Baclesse
Caen, France, 14076
4
Centre Jean Perrin
Clermont-Ferrand, France, 63011