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

August 21, 2018 updated by: Institut Claudius Regaud

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Institut de Cancérologie de l'Ouest - Centre Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Créteil, France, 94010
        • Hôpital Mondor
      • Lille, France, 59000
        • Centre OSCAR LAMBRET
      • Lyon, France, 69373
        • Centre LEON BERARD
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13273
        • Institut Paoli Calmette
      • Montpellier, France, 34298
        • Institut du Cancer de Montpellier - Val d'Aurelle
      • Nancy, France, 54411
        • Centre Alexis Vautrin
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Herblain (Nantes), France, 44805
        • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
      • Saint-Priest en Jarez, France, 42270
        • Institut de Cancerologie de La Loire
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiotherapy
Radiation: Radiotherapy
50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
Experimental: Absence of Radiotherapy
No Radiotherapy; Simple monitoring without active treatment
Other: absence of radiotherapy
absence of radiotherapy
Other Names:
  • Observation
  • Simple monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 2021
2021

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the quality of life by questionnaire of quality of life QLCQ30
Time Frame: 2021
2021
Evaluation of acute and late complications
Time Frame: 2009 to 2021
2009 to 2021
Overall Survival
Time Frame: 2021
2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Martine DELANNES, MD, Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2009

Primary Completion (Actual)

March 10, 2017

Study Completion (Actual)

March 10, 2017

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08SARC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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