Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT06022159

A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

Led by Institut Claudius Regaud · Updated on 2025-06-05

48

Participants Needed

11

Research Sites

283 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase II, multicenter, non-randomized study. The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma. A maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery. Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).

CONDITIONS

Official Title

A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed soft tissue sarcoma of the limbs or trunk
  • Indication for neo-adjuvant or adjuvant radiotherapy
  • Age 70 years or older with ECOG performance status 0 to 2, or age 65 to 70 years with ECOG 2 and identified as "fragile"
  • Affiliated with Social Health Insurance in France
  • Able and willing to give informed consent before any study procedures
Not Eligible

You will not qualify if you...

  • Retroperitoneal, ORL, or visceral sarcomas
  • Previous radiotherapy in the area of the tumor
  • Metastatic disease
  • Concurrent or sequential chemotherapy
  • Need for total surgery (amputation)
  • Other active cancer under treatment
  • Any condition preventing MRI
  • Psychological, familial, geographic, or social situation preventing consent or compliance
  • Participation in another therapeutic interventional trial
  • Under legal protection or deprived of freedom by administrative or legal order

AI-Screening

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Trial Site Locations

Total: 11 locations

1

Institut Bergonie

Bordeaux, France

Actively Recruiting

2

Centre Oscar Lambret

Lille, France

Actively Recruiting

3

Chu de Limoges

Limoges, France

Actively Recruiting

4

Centre Leon Berard

Lyon, France

Actively Recruiting

5

Institut Regional Du Cancer de Montpellier

Montpellier, France

Actively Recruiting

6

Institut Curie

Paris, France

Not Yet Recruiting

7

Chu de Poitiers

Poitiers, France

Actively Recruiting

8

Institut de Cancerologie de L'Ouest

Saint-Herblain, France

Actively Recruiting

9

Chu de Toulouse

Toulouse, France

Actively Recruiting

10

IUCT-O

Toulouse, France

Actively Recruiting

11

Institut Gustave Roussy

Villejuif, France

Actively Recruiting

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Research Team

J

Justine ATTAL KHALIFA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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