Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
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 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
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Angers, Frankrike, 49933
- Institut de Cancérologie de l'Ouest - Centre Paul Papin
-
Bordeaux, Frankrike, 33076
- Institut Bergonie
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Caen, Frankrike, 14076
- Centre François Baclesse
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Clermont Ferrand, Frankrike, 63011
- Centre Jean Perrin
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Créteil, Frankrike, 94010
- Hopital Mondor
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Lille, Frankrike, 59000
- Centre Oscar Lambret
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Lyon, Frankrike, 69373
- Centre Léon Bérard
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Marseille, Frankrike, 13385
- CHU de la Timone
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Marseille, Frankrike, 13273
- Institut Paoli Calmette
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Montpellier, Frankrike, 34298
- Institut du Cancer de Montpellier - Val d'Aurelle
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Nancy, Frankrike, 54411
- Centre Alexis Vautrin
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Nice, Frankrike, 06189
- Centre Antoine Lacassagne
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Rouen, Frankrike, 76038
- Centre Henri Becquerel
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Saint Herblain (Nantes), Frankrike, 44805
- Institut de Cancérologie de l'Ouest - Centre René Gauducheau
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Saint-Priest en Jarez, Frankrike, 42270
- Institut de Cancérologie de la Loire
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Strasbourg, Frankrike, 67065
- Centre Paul Strauss
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Toulouse, Frankrike, 31052
- Institut Claudius Regaud
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Villejuif, Frankrike, 94805
- Institut Gustave Roussy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Strålebehandling
|
50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
|
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Eksperimentell: Absence of Radiotherapy
No Radiotherapy; Simple monitoring without active treatment
|
absence of radiotherapy
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: 2021
|
2021
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Evaluation of the quality of life by questionnaire of quality of life QLCQ30
Tidsramme: 2021
|
2021
|
|
Evaluation of acute and late complications
Tidsramme: 2009 to 2021
|
2009 to 2021
|
|
Overall Survival
Tidsramme: 2021
|
2021
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Martine DELANNES, MD, Institut Claudius Regaud
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 08SARC01
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