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

Primary Purpose

Soft Tissue Sarcoma of Members

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Radiotherapy
absence of radiotherapy
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma of Members focused on measuring sarcoma, soft tissue, members, radiotherapy, absence of radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de l'Ouest - Centre Paul Papin
  • Institut Bergonié
  • Centre François Baclesse
  • Centre Jean Perrin
  • Hopital Mondor
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut Paoli Calmette
  • CHU de la Timone
  • Institut du Cancer de Montpellier - Val d'Aurelle
  • Centre Alexis Vautrin
  • Centre Antoine Lacassagne
  • Centre Henri Becquerel
  • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Institut de Cancerologie de La Loire
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Absence of Radiotherapy

Radiotherapy

Arm Description

No Radiotherapy; Simple monitoring without active treatment

Radiotherapy

Outcomes

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.

Secondary Outcome Measures

Evaluation of the quality of life by questionnaire of quality of life QLCQ30
Evaluation of acute and late complications
Overall Survival

Full Information

First Posted
March 26, 2009
Last Updated
August 21, 2018
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT00870701
Brief Title
Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment rate
Study Start Date
March 19, 2009 (Actual)
Primary Completion Date
March 10, 2017 (Actual)
Study Completion Date
March 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma of Members
Keywords
sarcoma, soft tissue, members, radiotherapy, absence of radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absence of Radiotherapy
Arm Type
Experimental
Arm Description
No Radiotherapy; Simple monitoring without active treatment
Arm Title
Radiotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
Intervention Type
Other
Intervention Name(s)
absence of radiotherapy
Other Intervention Name(s)
Simple monitoring, Observation
Intervention Description
absence of radiotherapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of the quality of life by questionnaire of quality of life QLCQ30
Time Frame
2021
Title
Evaluation of acute and late complications
Time Frame
2009 to 2021
Title
Overall Survival
Time Frame
2021

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine DELANNES, MD
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest - Centre Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Institut du Cancer de Montpellier - Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Alexis Vautrin
City
Nancy
ZIP/Postal Code
54411
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
City
Saint Herblain (Nantes)
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancerologie de La Loire
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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

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