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.

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcoma
• Interventions: Procedure: Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).; Procedure: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.

• Registration Number: NCT06022159
• Lead Sponsor: Institut Claudius Regaud

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-01
• Study Start: 2023-11-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-09
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant Cohort	Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).	-
Neo-adjuvant Cohort	Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.	3 years for each patient
Geriatric parameters evaluated using the G-CODE questionnaire.	3 years for each patient
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
Surgical complications evaluated according to NCI CTC AE V5 criteria.	3 years for each patient
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.	3 years for each patient
Healing time defined as the time between the date of surgery and the date of complete healing.	3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).	3 years for each patient
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
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).	3 years for each patient
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.	3 years for each patient

Trial Locations

Locations (11)

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, France