Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
This study is currently recruiting participants.
Verified November 2011 by Institut Claudius Regaud
Sponsor:
Institut Claudius Regaud
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00870701
First received: March 26, 2009
Last updated: November 23, 2011
Last verified: November 2011
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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:
|
|
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
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 | |
| Centre Paul Papin | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Pierre PABOT DU CHATELARD, MD +33 2 41 35 28 77 p.pabot@unimedia.fr | |
| Principal Investigator: Pierre PABOT DU CHATELARD, MD | |
| Institut Bergonié | Not yet recruiting |
| Bordeaux, France, 33076 | |
| Contact: Guy KANTOR, MD +33 5 56 33 33 44 kantor@bergonie.org | |
| Principal Investigator: Guy Kantor, MD | |
| Centre François Baclesse | Not yet recruiting |
| Caen, France, 14076 | |
| Contact: FLORIANE TOUDIC-EMILY, MD +33 2 31 45 50 20 f.todic@baclesse.fr | |
| Principal Investigator: FLORIANE TOUDIC-EMILY, MD | |
| Centre Jean Perrin | Not yet recruiting |
| Clermont Ferrand, France, 63011 | |
| Contact: PIERRE VERELLE, MD +33 4 73 27 81 42 Pierre.Verelle@cjp.fr | |
| Principal Investigator: PIERRE VERELLE, MD | |
| Hopital Mondor | Not yet recruiting |
| Créteil, France, 94010 | |
| Contact: Jean-Léon LAGRANGE, MD +33 1 49 81 45 24 jean-Léon.lagrange@hmn.aphp.fr | |
| Principal Investigator: Jean-Léon LAGRANGE, MD | |
| Centre Léon Bérard | Not yet recruiting |
| Lyon, France, 69373 | |
| Contact: Marie-Pierre SUNYACH, MD +33 4 78 78 28 28 sunyach@lyon.fnclcc.fr | |
| Principal Investigator: Marie-Pierre SUNYACH, MD | |
| CHU de la Timone | Not yet recruiting |
| Marseille, France, 13385 | |
| Contact: Didier COWEN, MD didier.cowen@ap-hm.fr | |
| Principal Investigator: Xavier MURACIOLE, MD | |
| Institut Paoli Calmette | Not yet recruiting |
| Marseille, France, 13273 | |
| Contact: Laurence MOUREAU-ZABOTTO, MD +33 4 91 22 36 37 moureaul@marseille.fnclcc.fr | |
| Principal Investigator: Laurence MOUREAU-ZABOTTO, MD | |
| Centre Val d'Aurelle | Not yet recruiting |
| Montpellier, France, 34298 | |
| Contact: Carmen LLACER-MOSCARDO, MD +33 4 67 61 31 42 carmen.llacer@valdorel.fnclcc.fr | |
| Principal Investigator: Carmen LLACER-MOSCARDO, MD | |
| Centre Alexis Vautrin | Not yet recruiting |
| Nancy, France, 54411 | |
| Contact: Véronique BECKENDORF, MD +33 3 83 59 84 27 v.beckendorf@nancy.fnclcc.fr | |
| Principal Investigator: Véronique BECKENDORF, MD | |
| Centre Eugène Marquis | Not yet recruiting |
| Rennes, France, 35042 | |
| Contact: M. BENCHALAL, MD +33 2 99 25 30 20 m.benchalal@rennes.fnclcc.fr | |
| Principal Investigator: M BENCHALAL, MD | |
| Centre René Gauducheau | Not yet recruiting |
| Saint Herblain (Nantes), France, 44805 | |
| Contact: Agnes CUSSAC, MD +33 2 40 67 99 55 a-cussac@nantes.fnclcc.fr | |
| Principal Investigator: Agnes CUSSAC, MD | |
| Institut Claudius Regaud | Recruiting |
| Toulouse, France, 31052 | |
| Contact: Martine DELANNES, MD +33 5.61.42.42.42 Delannes.Martine@claudiusregaud.fr | |
| Principal Investigator: Martine Delannes, MD | |
| CHU de Toulouse Rangueil | Not yet recruiting |
| Toulouse, France, 31403 | |
| Contact: Jean-Louis TRICOIRE, MD +33 5 61 32 20 23 tricoire.jl@chu-toulouse.fr | |
| Principal Investigator: Jean-Louis Tricoire, MD | |
| CHU de Toulouse Purpan | Not yet recruiting |
| Toulouse, France, 31059 | |
| Contact: Pierre BONNEVIALE, MD +33 5 61 77 21 04 bonneviale.p@chu-toulouse.fr | |
| Principal Investigator: Pierre Bonneviale, MD | |
| IGR | Not yet recruiting |
| Villejuif, France, 94805 | |
| Contact: Cécile LEPECHOUX, MD +33 142 11 47 57 lepechoux@igr.fr | |
| 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: | November 23, 2011 |
| 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, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013