Evaluating radiation therapy for older patients with soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, multicenter, non-randomized study aims to assess the effects of hypofractionated radiation therapy on wound healing in older or fragile patients diagnosed with soft tissue sarcoma. The study includes two cohorts: one receiving radiation therapy before surgery (neo-adjuvant) and another receiving it after surgery (adjuvant). A total of 70 patients will be enrolled, with each patient followed for up to three years post-treatment to evaluate outcomes. The focus is on patients aged 65 and older, particularly those identified as fragile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.
2. Indication for neo-adjuvant or adjuvant radiotherapy.
3. 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".
4. Patient affiliated to a Social Health Insurance in France.
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.

Exclusion Criteria:

1. Retroperitoneal, ORL and visceral sarcomas.
2. Previous radiotherapy in the area.
3. Metastatic disease.
4. Concomitant or sequential chemotherapy.
5. Patient requiring total surgery (amputation).
6. Other cancer under treatment.
7. Any condition or pathology contraindicating MRI.
8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.
9. Patients included in another therapeutic interventional trial.
10. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Where it's running

• Institut Bergonie
  Bordeaux, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• Chu de Limoges
  Limoges, France Recruiting
• Centre Leon Berard
  Lyon, France Recruiting
• Institut Regional Du Cancer de Montpellier
  Montpellier, France Recruiting
• Institut Curie
  Paris, France Recruiting

Study contacts

• Study coordinator: Justine ATTAL KHALIFA
• Email: AttalKhalifa.Justine@iuct-oncopole.fr
• Phone: 05 31 15 54 38

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.