Actively Recruiting
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
Eligibility Criteria
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
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
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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