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Brief Title: Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
Official Title: 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.
Study ID: NCT00870701
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 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Name: Martine DELANNES, MD
Affiliation: Institut Claudius Regaud
Role: PRINCIPAL_INVESTIGATOR