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Recruiting nowPhase 2Ages 16 Years and up

Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma

Sponsor: Institut Claudius Regaud · NCT04515459 on ClinicalTrials.gov ↗

Conditions studied

Sarcoma

What it tests

  • Surgical prehabilitation program.other

Where it's running1 site

1 international site
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

1. Age \> or = 16 years old.
2. Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "Réseau de Relecture en Pathologie Sarcomateuse (RRePS)"
3. Tumour localized in the lower or upper limb.
4. Localized or metastatic disease (in case of metastatic disease, the optimal surgical treatment for the primary tumor must be performed).
5. Indication of neoadjuvant treatment (radiotherapy and/or chemotherapy) according to the Multidisciplinary Concertation Meeting.
6. Inclusion before the initiation or during neoadjuvant treatment. In both cases, surgery must be scheduled between 6 and 10 weeks after inclusion, to permit the completion of the surgical prehabilitation.
7. Patient must provide written informed consent prior to any study-specific procedure. For minor patients, the holder(s) of parental authority must sign the informed consent and the patient's assent must be obtained.
8. Patient affiliated to the French social security system.

Exclusion Criteria:

1. Metastatic disease without optimal surgery planned of the primary tumour.
2. Any disease or medical condition that could interfere with study procedure, or that could, according to the judgment of investigator, expose the patient to an unacceptable risk.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
4. Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure.
5. Pregnant or breastfeeding patient.

Updated 2025-09-15 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.