Evaluating radiation therapy for older patients with 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.
This study is testing a type of radiation therapy to see if it helps older patients with soft tissue sarcoma heal better after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 11 sites (Bordeaux and 10 other locations) |
| Trial ID | NCT06022159 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 years and older with histologically confirmed soft tissue sarcoma of the limbs or trunk.
Not a fit: Patients with metastatic disease, previous radiotherapy in the area, or requiring total surgery (amputation) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve wound healing and overall treatment outcomes for older patients with soft tissue sarcoma.
How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promise in treating older patients with various cancers using hypofractionated radiation therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux and 10 other locations
- 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 (Not_yet_recruiting)
- Chu de Poitiers — Poitiers, France (Recruiting)
- Institut de Cancerologie de L'Ouest — Saint-Herblain, France (Recruiting)
- Chu de Toulouse — Toulouse, France (Recruiting)
- Iuct-O — Toulouse, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Justine ATTAL KHALIFA
- Email: AttalKhalifa.Justine@iuct-oncopole.fr
- Phone: 05 31 15 54 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.