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

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ClinicalTrials.gov Identifier: NCT00870701
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma of Members Radiation: Radiotherapy Other: absence of radiotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 19, 2009
Actual Primary Completion Date : March 10, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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. [ Time Frame: 2021 ]

Secondary Outcome Measures :
  1. Evaluation of the quality of life by questionnaire of quality of life QLCQ30 [ Time Frame: 2021 ]
  2. Evaluation of acute and late complications [ Time Frame: 2009 to 2021 ]
  3. Overall Survival [ Time Frame: 2021 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870701


Locations
France
Institut de Cancérologie de l'Ouest - Centre Paul Papin
Angers, France, 49933
Institut Bergonié
Bordeaux, France, 33076
Centre François Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont Ferrand, France, 63011
Hopital Mondor
Créteil, France, 94010
Centre Oscar Lambret
Lille, France, 59000
Centre Léon Bérard
Lyon, France, 69373
Institut Paoli Calmette
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298
Centre Alexis Vautrin
Nancy, France, 54411
Centre Antoine Lacassagne
Nice, France, 06189
Centre Henri Becquerel
Rouen, France, 76038
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint Herblain (Nantes), France, 44805
Institut de Cancerologie de La Loire
Saint-Priest en Jarez, France, 42270
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius Regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Martine DELANNES, MD Institut Claudius Regaud

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00870701     History of Changes
Other Study ID Numbers: 08SARC01
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Keywords provided by Institut Claudius Regaud:
sarcoma
soft tissue
members
radiotherapy
absence of radiotherapy

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms