Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma

Phase 3

Terminated

• Conditions: Soft Tissue Sarcoma of Members
• Interventions: Other: absence of radiotherapy; Radiation: Radiotherapy

• Registration Number: NCT00870701
• Lead Sponsor: Institut Claudius Regaud

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

Not available

Study Timeline

• Study Start: 2009-03-19
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2017-03-10
• Study Completion: 2017-03-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absence of Radiotherapy	absence of radiotherapy	No Radiotherapy; Simple monitoring without active treatment
Radiotherapy	Radiotherapy	Radiotherapy

Primary Outcome Measures

Name	Time	Method
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.	2021

Secondary Outcome Measures

Name	Time	Method
Evaluation of the quality of life by questionnaire of quality of life QLCQ30	2021
Overall Survival	2021
Evaluation of acute and late complications	2009 to 2021

Trial Locations

Locations (18)

Institut de Cancerologie de La Loire; 🇫🇷 Saint-Priest en Jarez, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Centre Alexis Vautrin; 🇫🇷 Nancy, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut de Cancérologie de l'Ouest - Centre René Gauducheau; 🇫🇷 Saint Herblain (Nantes), France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut de Cancérologie de l'Ouest - Centre Paul Papin; 🇫🇷 Angers, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hopital Mondor; 🇫🇷 Créteil, France

CHU de la Timone; 🇫🇷 Marseille, France

Institut du Cancer de Montpellier - Val d'Aurelle; 🇫🇷 Montpellier, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France