Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or Fragile (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.

• Indication for neo-adjuvant or adjuvant radiotherapy.

• Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years with an ECOG of 2 and identified by the investigator as fragile.

• Patient affiliated to a Social Health Insurance in France.

• Patient able to participate and willing to give informed consent prior performance of any study-related procedures.

Locations
Other Locations
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Oscar Lambret
RECRUITING
Lille
Chu de Limoges
RECRUITING
Limoges
Centre Leon Berard
RECRUITING
Lyon
Institut Regional Du Cancer de Montpellier
RECRUITING
Montpellier
Institut Curie
NOT_YET_RECRUITING
Paris
Chu de Poitiers
RECRUITING
Poitiers
Institut de Cancerologie de L'Ouest
RECRUITING
Saint-herblain
Chu de Toulouse
RECRUITING
Toulouse
IUCT-O
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Justine ATTAL KHALIFA
AttalKhalifa.Justine@iuct-oncopole.fr
05 31 15 54 38
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2029-05
Participants
Target number of participants: 48
Treatments
Experimental: Radiation therapy followed by surgery
Related Therapeutic Areas
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov