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Tests treatment safety and results for Sarcoma
Official title Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
ClinicalTrials.gov ID: NCT04515459
What this study is testing
- What it's testing
- 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. This protocol will be based on the realisation of a surgical prehabilitation program adapted to the patient.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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.
You likely can't join if
- 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 who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection...
- Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure.
- Pregnant or breastfeeding patient.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.