Status:
RECRUITING
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Sarcoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
This Phase II feasibility study, prospective, interventional, monocentric aiming to assess the interest of pre-operative rehabilitation in patients treated for bone or soft-tissue sarcoma of the limbs...
Eligibility Criteria
Inclusion
- Age \> or = 16 years old.
- Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "Réseau de Relecture en Pathologie Sarcomateuse (RRePS)"
- Tumour localized in the lower or upper limb.
- Localized or metastatic disease (in case of metastatic disease, the optimal surgical treatment for the primary tumor must be performed).
- Indication of neoadjuvant treatment (radiotherapy and/or chemotherapy) according to the Multidisciplinary Concertation Meeting.
- 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.
- 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.
- Patient affiliated to the French social security system.
Exclusion
- Metastatic disease without optimal surgery planned of the primary tumour.
- 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.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
- Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure.
- Pregnant or breastfeeding patient.
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04515459
Start Date
September 13 2022
End Date
November 1 2029
Last Update
September 15 2025
Active Locations (1)
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1
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France