Fact CheckerSign in

NCT06022159RecruitingPhase 2

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.

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.

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
48 (estimated)
First submitted
16 Aug 2023
Start date
28 Nov 2023
Primary completion date
Sept 2026
Lead sponsor
Institut Claudius Regaud
Diseases
Sarcoma
NCT number
NCT06022159

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 48
  • From 28 Nov 2023 to the primary completion date, Sept 2026
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous radiotherapy in the area.
  • Concomitant or sequential chemotherapy.
  • Patient requiring total surgery (amputation).

Other illness

  • Metastatic disease.
  • Other cancer under treatment.
  • Any condition or pathology contraindicating MRI.

Other

  • Retroperitoneal, ORL and visceral sarcomas.
  • Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.
  • Patients included in another therapeutic interventional trial.
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Who the study is looking for

  • 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.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Bergonie
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceRecruiting
CHU de Limoges
Coordinator of this site? Confirm its status
LimogesFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Institut Regional Du Cancer de Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
Institut Curie
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceRecruiting
Institut de Cancérologie de l'Ouest
Coordinator of this site? Confirm its status
Saint-HerblainFranceRecruiting
IUCT-O
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHU de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.