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

NCT00870701 | Terminated Phase 3 DMC

• 1 other identifier: 08SARC01
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 18

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.

Conditions

Soft Tissue Sarcoma of Members

Keywords

sarcoma; soft tissue; members; radiotherapy; absence of radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of the quality of life by questionnaire of quality of life QLCQ30

  2021

• Evaluation of acute and late complications

  2009 to 2021

• Overall Survival

  2021

Study Arms (2)

Absence of Radiotherapy

EXPERIMENTAL

No Radiotherapy; Simple monitoring without active treatment

Other: absence of radiotherapy

Radiotherapy

ACTIVE COMPARATOR

Radiotherapy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays

Radiotherapy

absence of radiotherapy OTHER

absence of radiotherapy

Also known as: Simple monitoring, Observation

Absence of Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (18)

Institut de Cancérologie de l'Ouest - Centre Paul Papin

Angers, 49933, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Mondor

Créteil, 94010, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

Location

Centre Alexis Vautrin

Nancy, 54411, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de Cancérologie de l'Ouest - Centre René Gauducheau

Saint Herblain (Nantes), 44805, France

Location

Institut de Cancerologie de La Loire

Saint-Priest-en-Jarez, 42270, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy; Observation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Methods; Investigative Techniques

Study Officials

• Martine DELANNES, MD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 19, 2009
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

FR (18)