SarcomaPhase 2EPOP-SARCOMANCT04515459
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
A Phase 2 study testing Surgical prehabilitation program. in people with Sarcoma, run by Institut Claudius Regaud at 1 site in France.
Trial 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. This protocol will be based on the realisation of a surgical prehabilitation program adapted to the patient. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Surgical prehabilitation program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2022to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse
Dimitri GANGLOFF, 05 31 15 53 58, gangloff.dimitri@iuct-oncopole.fr
About this study
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. This strategy will involve a team of several health professionals: rehabilitation doctor, physiotherapist, occupational therapist, specialised nurse, dietician and adapted physical activity teacher.
Read more
The aim of an adapted surgical prehabilitation program is to improve the functional recovery of the treated limb and the patient's autonomy after surgery.
Each patient will be followed until 24 months post surgery.
- Conditions
- Sarcoma
- Being tested
- Surgical prehabilitation program.
- Keywords
- Bone sarcoma, Soft-tissue sarcoma, Pre-operative prehabilitation
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical prehabilitation program.Other
This programme will include the practice of general physical activity and the implementation of nutritional and psychological support.
Each patient will have 8 Oncorehabilitation Transdisciplinary Evaluations (OTE):
- 2 OTE will be performed before the surgery,
- 6 OTE will be performed after the surgery.
During the program (at each OTE), patients will also be asked to complete the QLQ-C30 questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for bone or soft-tissue sarcoma of the limbs | Other | Not described Receives: Other: Surgical prehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with a MSTS score (Musculoskeletal Tumor Rating Scale) greater than 75% at 24 months post-surgery.
Measured: 26 months for each patient.
Secondary outcomes (10)
Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).
Quality of life will be evaluated from OTE1 to OTE8.
Measured: 26 months for each patient.
Anxiety using the Hospital Anxiety and Depression Scale (HADS).
Seven item subscale. Each item is scored on a 4-point scale. Anxiety will be evaluated from OTE1 to OTE8.
Measured: 26 months for each patient.
Depression using the Hospital Anxiety and Depression Scale (HADS).
Seven item subscale. Each item is scored on a 4-point scale. Depression will be evaluated from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the Tinetti's test from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the 6-min walk test from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the New Functional Ambulation Classification test from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the Box and Block Test from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the Frenchay Arm Test from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the Visual Analog Scale from OTE1 to OTE8.
Measured: 26 months for each patient.
The patient functionality will be evaluated using the Ricci and Gagnon's Score from OTE1 to OTE8.
Measured: 26 months for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start13 Sep 2022
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515459
- Sponsor's protocol ID
- 20 SARC 03
- Acronym
- EPOP-SARCOMA
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
- ClinicalTrials.gov ID
- NCT04515459
- Acronym / sponsor ID
- EPOP-SARCOMA / 20 SARC 03
- Conditions
- Sarcoma
- Keywords
- Bone sarcoma, Soft-tissue sarcoma, Pre-operative prehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This strategy will involve a team of several health professionals: rehabilitation doctor, physiotherapist, occupational therapist, specialised nurse, dietician and adapted physical activity teacher.
The aim of an adapted surgical prehabilitation program is to improve the functional recovery of the treated limb and the patient's autonomy after surgery.
Each patient will be followed until 24 months post surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for bone or soft-tissue sarcoma of the limbs | Other | Other: Surgical prehabilitation program. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical prehabilitation program.This programme will include the practice of general physical activity and the implementation of nutritional and psychological support. Each patient will have 8 Oncorehabilitation Transdisciplinary Evaluations (OTE): * 2 OTE will be performed before the surgery, * 6 OTE will be performed after the surgery. During the program (at each OTE), patients will also be asked to complete the QLQ-C30 questionnaire. | Other | Patients treated for bone or soft-tissue sarcoma of the limbs |
Primary outcome
Rate of patients with a MSTS score (Musculoskeletal Tumor Rating Scale) greater than 75% at 24 months post-surgery.
Time frame: 26 months for each patient.
10 secondary outcomes
Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).
Time frame: 26 months for each patient.
Anxiety using the Hospital Anxiety and Depression Scale (HADS).
Time frame: 26 months for each patient.
Depression using the Hospital Anxiety and Depression Scale (HADS).
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Tinetti's test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the 6-min walk test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the New Functional Ambulation Classification test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Box and Block Test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Frenchay Arm Test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Visual Analog Scale from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Ricci and Gagnon's Score from OTE1 to OTE8.
Time frame: 26 months for each patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical prehabilitation program. in people with Sarcoma, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitri GANGLOFF (05 31 15 53 58, gangloff.dimitri@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with a MSTS score (Musculoskeletal Tumor Rating Scale) greater than 75% at 24 months post-surgery. (time frame: 26 months for each patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.