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

NCT00870701 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2018-08-22

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma of Members

Interventions

RADIATION

Radiotherapy

50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays

OTHER

absence of radiotherapy

absence of radiotherapy

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Martine DELANNES, MD · Institut Claudius Regaud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-19
Primary Completion
2017-03-10
Completion
2017-03-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870701 on ClinicalTrials.gov