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. (HYPOSARC)

May 29, 2026 updated by: Institut Claudius Regaud

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 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation therapy followed by surgery
Radiation: Hypofractionated Radiation Therapy
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.
Other Names:
  • Intensity-modulated radiation therapy (IMRT)
Procedure: Conservative treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
Time Frame: 6 month for each patient
6 month for each patient

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 SARC 01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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