Clinical trial NCT00870701: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Soft Tissue Sarcoma of Members
Keywords: sarcoma
soft tissue
members
radiotherapy
absence of radiotherapy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2021
Secondary outcomes:
measure: Evaluation of the quality of life by questionnaire of quality of life QLCQ30
timeFrame: 2021
measure: Evaluation of acute and late complications
timeFrame: 2009 to 2021
measure: Overall Survival
timeFrame: 2021
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Créteil
country: France
facility: Hopital Mondor
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Marseille
country: France
facility: CHU de la Timone
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier - Val d'Aurelle
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Herblain (Nantes)
country: France
facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancerologie de La Loire
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Claudius Regaud
name: Martine DELANNES, MD
role: PRINCIPAL_INVESTIGATOR
References: