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.

NCT06022159 | Recruiting Phase 2 DMC

• 1 other identifier: 23 SARC 01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 11

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 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).

Conditions

Soft Tissue Sarcoma

Keywords

Soft Tissue Sarcoma; Limb soft tissue SARComa; Trunk soft tissue SARComa; Aged population; "Fragile" population; hypofractionated radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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-C30).

  3 years for each patient

Study Arms (1)

Radiation therapy followed by surgery

EXPERIMENTAL

Radiation: Hypofractionated Radiation Therapy; Procedure: Conservative treatment

Interventions

Hypofractionated Radiation Therapy RADIATION

The Hypofractionated Intensity-Modulated Radiation Therapy will be delivered in 5 fractions of 6 Gy each on the Planning Target Volume (PTV). The total dose of 30 Gy will be administered in approximately 1 week.

Also known as: Intensity-modulated radiation therapy (IMRT)

Radiation therapy followed by surgery

Conservative treatment PROCEDURE

A wide en bloc resection is required (amputation is excluded) while ensuring the best functional preservation. The surgical procedure will take place about 1,5 to 2 months after the end of the radiation therapy.

Radiation therapy followed by surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Retroperitoneal, ORL and visceral sarcomas.
• Previous radiotherapy in the area.
• Metastatic disease.
• Concomitant or sequential chemotherapy.
• Patient requiring total surgery (amputation).
• Other cancer under treatment.
• Any condition or pathology contraindicating MRI.
• 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).

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (11)

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

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy, Intensity-Modulated; Conservative Treatment

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Justine ATTAL KHALIFA

CONTACT

05 31 15 54 38; AttalKhalifa.Justine@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radiation therapy followed by surgery

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 1, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (11)