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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.

ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorInstitut Claudius Regaud

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Retroperitoneal, ORL and visceral sarcomas.

Previous radiotherapy in the area.

Metastatic disease.

Concomitant or sequential chemotherapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Conservative treatment

    Procedure/Surgery

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Radiation therapy followed by surgeryExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Claudius Regaud

Lead sponsor

Source ClinicalTrials.gov
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