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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Institut Claudius Regaud
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00870701
First received: March 26, 2009
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Soft Tissue Sarcoma of Members
Radiation: Radiotherapy
Other: absence of radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the quality of life by questionnaire of quality of life QLCQ30 [ Time Frame: 2021 ] [ Designated as safety issue: Yes ]
  • Evaluation of acute and late complications [ Time Frame: 2009 to 2021 ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 2021 ] [ Designated as safety issue: No ]

Estimated Enrollment: 570
Study Start Date: March 2009
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870701

Contacts
Contact: Martine DELANNES, MD +33 5 61 42 42 42 delannes.martine@claudiusregaud.fr
Contact: Muriel POUBLANC + 33 5 61 42 46 74 Poublanc.Muriel@claudiusregaud.fr

Locations
France
Institut de Cancérologie de l'Ouest - Centre Paul Papin Recruiting
Angers, France, 49933
Contact: Hadji HAMIDOU, MD    +33 2 41 35 28 77      
Principal Investigator: Hadji HAMIDOU, MD         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Guy KANTOR, MD    +33 5 56 33 33 44      
Principal Investigator: Guy Kantor, MD         
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: Corinne DELCAMBRE-LAIR, MD    +33 2 31 45 50 20      
Principal Investigator: Corinne DELCAMBRE-LAIR, MD         
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Contact: Michel LAPEYRE, MD    +33 4 73 27 81 42      
Principal Investigator: Michel LAPEYRE, MD         
Hopital Mondor Recruiting
Créteil, France, 94010
Contact: Jean-Léon LAGRANGE, Pr.    +33 1 49 81 45 24      
Principal Investigator: Jean-Léon LAGRANGE, Pr.         
Centre Oscar Lambret Recruiting
Lille, France, 59000
Contact: Abel CORDOBA LARGO, Md.    03 20 29 59 59 ext +33      
Principal Investigator: Abel CORDOBA LARGO, Md.         
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Marie-Pierre SUNYACH, MD    +33 4 78 78 28 28      
Principal Investigator: Marie-Pierre SUNYACH, MD         
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Didier COWEN, MD       didier.cowen@ap-hm.fr   
Principal Investigator: Didier COWEN, MD         
Institut Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Laurence MOUREAU-ZABOTTO, MD    +33 4 91 22 36 37      
Principal Investigator: Laurence MOUREAU-ZABOTTO, MD         
Institut du Cancer de Montpellier - Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Carmen LLACER-MOSCARDO, MD    +33 4 67 61 31 42      
Principal Investigator: Carmen LLACER-MOSCARDO, MD         
Centre Alexis Vautrin Recruiting
Nancy, France, 54411
Contact: Véronique BECKENDORF, MD    +33 3 83 59 84 27      
Principal Investigator: Véronique BECKENDORF, MD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Juliette THARIAT, Md.    04 92 03 12 68 ext +33      
Principal Investigator: Juliette THARIAT, Md.         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Chantal HANZEN, Md.    02 32 08 25 15 ext +33      
Principal Investigator: Chantal HANZEN, Md.         
Institut de Cancérologie de l'Ouest - Centre René Gauducheau Recruiting
Saint Herblain (Nantes), France, 44805
Contact: Augustin MERVOYER, MD    +33 2 40 67 99 55      
Principal Investigator: Augustin MERVOYER, MD         
Institut de Cancerologie de La Loire Recruiting
Saint-Priest en Jarez, France, 42270
Contact: Guy DE LAROCHE, Md.    04 77 91 70 00 ext +33      
Principal Investigator: Guy DE LAROCHE, Md.         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Georges NOEL, Pr.    03 88 25 24 56 ext +33      
Principal Investigator: Georges NOEL, Pr.         
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Martine DELANNES, MD    +33 5.61.42.42.42      
Principal Investigator: Martine Delannes, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Cécile LEPECHOUX, MD    +33 142 11 47 57      
Principal Investigator: Cécile LEPECHOUX, MD         
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Martine DELANNES, MD Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00870701     History of Changes
Other Study ID Numbers: 08SARC01
Study First Received: March 26, 2009
Last Updated: September 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 20, 2014