Soft Tissue SarcomaPhase 2HYPOSARCNCT06022159
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.
A Phase 2 study testing Hypofractionated Radiation Therapy and Conservative treatment in people with Soft Tissue Sarcoma, run by Institut Claudius Regaud at 11 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Hypofractionated Radiation Therapy and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesFrance
- Study dates
- 28 Nov 2023to May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures.
Who cannot join
- Retroperitoneal, ORL and visceral sarcomas.
- Previous radiotherapy in the area.
- Metastatic disease.
- Concomitant or sequential chemotherapy.
- Patient requiring total surgery (amputation).
- Other cancer under treatment.
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- Any condition or pathology contraindicating MRI.
- Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.
- Patients included in another therapeutic interventional trial.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Institut Bergonie
Bordeaux
Pauline GILLON, 05 56 33 33 43, p.gillon@bordeaux.unicancer.fr
- Recruiting
Centre Oscar Lambret
Lille
Abel CORDOBA LARGO, 03 20 29 59 59, a-cordoba@o-lambret.fr
- Recruiting
Chu de Limoges
Limoges
Hélène ORLIAC, 05 55 05 62 68, helene.orliac@chu-limoges.fr
- Recruiting
Centre Leon Berard
Lyon
Waisse WAISSI, 04 78 78 28 28, waisse.waissi@lyon.unicancer.fr
- Recruiting
Institut Regional Du Cancer de Montpellier
Montpellier
Carmen LLACER-MOSCARDO, 04 67 61 37 79, carmen.llacer@icm.unicancer.fr
- Recruiting
Institut Curie
Paris
Sylvie HELFRE, 01 44 32 46 25, sylvie.helfre@curie.net
- Recruiting
Chu de Poitiers
Poitiers
Sarah GARCIA MOLINA, 05 49 44 44 44, sarah.garcia-molina@chu-poitiers.fr
- Recruiting
Institut de Cancerologie de L'Ouest
Saint-Herblain
Augustin MERVOYER, 02 40 67 99 00, augustin.mervoyer@ico.unicancer.fr
- Recruiting
Chu de Toulouse
Toulouse
Louis COURTOT, 05 61 77 21 04, courtot.l@chu-toulouse.fr
- Recruiting
IUCT-O
Toulouse
Justine ATTAL KHALIFA, 05 31 15 54 38, attalkhalifa.justine@iuct-oncopole.fr
- Recruiting
Institut Gustave Roussy
Villejuif
Cécile LE PECHOUX, 01 42 11 42 11, cecile.lepechoux@gustaveroussy.fr
About this study
Official title: Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
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).
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Hypofractionated Radiation Therapy, Conservative treatment
- Keywords
- Soft Tissue Sarcoma, Limb soft tissue SARComa, Trunk soft tissue SARComa, Aged population, "Fragile" population, hypofractionated radiation therapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Also called Intensity-modulated radiation therapy (IMRT)
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 treatmentProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy followed by surgery | Experimental | Not described Receives: Radiation: Hypofractionated Radiation Therapy; Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
Measured: 6 month for each patient
Secondary outcomes (10)
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.
Measured: 3 years for each patient
Surgical complications evaluated according to NCI CTC AE V5 criteria.
Measured: 3 years for each patient
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
Measured: 3 years for each patient
Healing time defined as the time between the date of surgery and the date of complete healing.
Measured: 3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
Measured: 3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
Measured: 3 years for each patient
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
Measured: 3 years for each patient
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
Measured: 3 years for each patient
Geriatric parameters evaluated using the G-CODE questionnaire.
Measured: 3 years for each patient
Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
Measured: 3 years 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 posted1 Sep 2023
- Study start28 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiation therapy followed by surgery
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT06022159
- Sponsor's protocol ID
- 23 SARC 01
- Acronym
- HYPOSARC
- Status last verified
- May 2026
- First submitted
- 16 Aug 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
- ClinicalTrials.gov ID
- NCT06022159
- Acronym / sponsor ID
- HYPOSARC / 23 SARC 01
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, Limb soft tissue SARComa, Trunk soft tissue SARComa, Aged population, "Fragile" population, hypofractionated radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 1 Sep 2023 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation therapy followed by surgery
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy followed by surgery | Experimental | Radiation: Hypofractionated Radiation Therapy, Procedure: Conservative treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures.
Key exclusion criteria (10 listed)
- Retroperitoneal, ORL and visceral sarcomas.
- Previous radiotherapy in the area.
- Metastatic disease.
- Concomitant or sequential chemotherapy.
- Patient requiring total surgery (amputation).
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 |
|---|---|---|
| Hypofractionated Radiation TherapyAlso: Intensity-modulated radiation therapy (IMRT)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. | Radiation | Radiation therapy followed by surgery |
| Conservative treatmentA 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. | Procedure or surgery | Radiation therapy followed by surgery |
Primary outcome
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
10 secondary outcomes
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
Surgical complications evaluated according to NCI CTC AE V5 criteria.
Time frame: 3 years for each patient
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
Time frame: 3 years for each patient
Healing time defined as the time between the date of surgery and the date of complete healing.
Time frame: 3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
Time frame: 3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
Time frame: 3 years for each patient
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
Time frame: 3 years for each patient
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
Time frame: 3 years for each patient
Geriatric parameters evaluated using the G-CODE questionnaire.
Time frame: 3 years for each patient
Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
Time frame: 3 years 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 2 Jun 2026.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated Radiation Therapy and Conservative treatment in people with Soft Tissue Sarcoma, run by Institut Claudius Regaud at 11 sites 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 5 inclusion and 10 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Justine ATTAL KHALIFA (05 31 15 54 38, AttalKhalifa.Justine@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 2 Jun 2026.