Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
NCT ID: NCT00870701
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
77 participants
INTERVENTIONAL
2009-03-19
2017-03-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Absence of Radiotherapy
No Radiotherapy; Simple monitoring without active treatment
absence of radiotherapy
absence of radiotherapy
Radiotherapy
Radiotherapy
Radiotherapy
50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
Interventions
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Radiotherapy
50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
absence of radiotherapy
absence of radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Principal Investigators
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Martine DELANNES, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud
Locations
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Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Institut de Cancérologie de l'Ouest - Centre Paul Papin
Angers, , France
Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Mondor
Créteil, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmette
Marseille, , France
CHU de la Timone
Marseille, , France
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, , France
Centre Alexis Vautrin
Nancy, , France
Centre Antoine Lacassagne
Nice, , France
Centre Henri Becquerel
Rouen, , France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint Herblain (Nantes), , France
Institut de Cancerologie de La Loire
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
Countries
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Other Identifiers
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08SARC01
Identifier Type: -
Identifier Source: org_study_id
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