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NCT Number: NCT06022159

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.

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).

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonie, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: Intensity-modulated radiation therapy (IMRT)

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Surgical complications evaluated according to NCI CTC AE V5 criteria.

    Time frame: 3 years for each patient

  3. Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.

    Time frame: 3 years for each patient

  4. Healing time defined as the time between the date of surgery and the date of complete healing.

    Time frame: 3 years for each patient

  5. Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).

    Time frame: 3 years for each patient

  6. Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).

    Time frame: 3 years for each patient

  7. Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.

    Time frame: 3 years for each patient

  8. Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.

    Time frame: 3 years for each patient

  9. Geriatric parameters evaluated using the G-CODE questionnaire.

    Time frame: 3 years for each patient

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Justine ATTAL KHALIFA

CONTACT

[email protected]

05 31 15 54 38

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study title

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.

Acronym: HYPOSARC

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Sep 1, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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