A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

Soft Tissue Sarcoma Clinical Trial

— HYPOSARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022159
• Other study ID #: 23 SARC 01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 28, 2023
• Est. completion date: May 2029

Study information

• Verified date: May 2024
• Source: Institut Claudius Regaud
• Contact: Justine ATTAL KHALIFA
• Phone: 05 31 15 54 38
• Email: AttalKhalifa.Justine[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and 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 70 patients will be included in this study, divided in 2 groups (35 patients per arms): a neo-adjuvant cohort and an adjuvant cohort. In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior to surgery. In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated radiation therapy. Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery or surgery + radiotherapy).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2029
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Procedure:
• Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.
Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy. Post-operative follow-up: post-operative complications will be followed at 3 and 6 weeks post-surgery. A visit at 6 months post-surgery will also be carried out to evaluate post-operative complications and late adverse effects of radiotherapy. Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).
• Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).
Post-operative follow-up: postoperative complications will be followed at 3 and 6 weeks post-surgery (before the start of irradiation). Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy. A 6-month post-surgery check-up will also be carried out to assess post-operative complications and acute side effects of radiotherapy. Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Centre Oscar Lambret	Lille
France	Chu de Limoges	Limoges
France	Centre Leon Berard	Lyon
France	Institut Regional Du Cancer de Montpellier	Montpellier
France	Institut Curie	Paris
France	Chu de Poitiers	Poitiers
France	Institut de Cancerologie de L'Ouest	Saint-Herblain
France	Chu de Toulouse	Toulouse
France	IUCT-O	Toulouse
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.		6 month for each patient
Secondary	Patients' disease-free survival defined as the time between the inclusion date and the occurrence of a carcinological event (local recurrence, distant metastasis) or death from any cause.		3 years for each patient
Secondary	Surgical complications evaluated according to NCI CTC AE V5 criteria.		3 years for each patient
Secondary	Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.		3 years for each patient
Secondary	Healing time defined as the time between the date of surgery and the date of complete healing.		3 years for each patient
Secondary	Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).		3 years for each patient
Secondary	Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).		3 years for each patient
Secondary	Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.		3 years for each patient
Secondary	Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.		3 years for each patient
Secondary	Geriatric parameters evaluated using the G-CODE questionnaire.		3 years for each patient
Secondary	Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.		3 years for each patient