Soft Tissue Sarcoma AdultPhase 2NEORASARCNCT07507773
Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall
A Phase 2 study testing Moderately hypofractionated neoadjuvant radiotherapy in people with Soft Tissue Sarcoma Adult and Soft Tissue Sarcoma (Excluding GIST), run by Centre Oscar Lambret at 1 site in France.
Trial summary
This trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall. The primary outcome is local disease control, assessed by the cumulative incidence of progression/recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities
- What is being tested?
- Moderately hypofractionated neoadjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2026to 1 Jun 2035
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years ;
- Localised sarcoma of a limb, the root of a limb, or the trunk wall ;
- Histologically confirmed diagnosis of soft tissue sarcoma regardless of the grade ;
- Diagnosis biopsy performed at Centre Oscar Lambret, with specimen available for translational research ;
- Indication of neoadjuvant radiotherapy according to the multidisciplinary consultation meeting ;
- Tumor considered operable with a curative intent and conservative intent according to the multidisciplinary consultation meeting ;
- Affiliation to the French National Social Security System ;
- Informed and signed consent
Who cannot join
- Metastatic disease (including local lymph node diffusion) ;
- Visceral or retroperitoneal sarcoma ;
- Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;
- Indication of neoadjuvant or adjuvant chemotherapy ;
- Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;
- Pregnant or breastfeeding women ;
- Patients under protective measures ;
- Patient refusal.
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
Centre Oscar Lambret
Lille, 59000
Abel CORDOBA, MD, +33(0)20295920, a-cordoba@o-lambret.fr
Abel CORDOBA, MD
About this study
Official title: Phase II Clinical Trial Assessing the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall, Incorporating Translationnal Research
This trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall. The primary outcome is local disease control, assessed by the cumulative incidence of progression/recurrence.
After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed followed by the experimental treatment: intensity-modulated radiotherapy with a moderately hypofractionated regimen consisting in 15 fractions of 2.7 Gy administered over 3 weeks.
Read more
a follow-up assessment will be performed 3 to 4 weeks after the last radiotherapy session.
Tumor resection will be performed 4 to 8 weeks after the radiotherapy. Patients will then be followed up until the end of the study; planned 5 years after the last inclusion.
Radiotherapy will be evaluated in terms of safety and efficacy.
Read the detailed description
The NEORASARC clinical trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall.
After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed 8 weeks prior to the start of experimental treatment. This baseline assessment will consist in of a clinical examination, an MRI scan, and the completion of the MSTS and QLQ-C30 questionnaires. After a blood sample has been taken for translational research, the patient will receive the experimental treatment : intensity-modulated radiotherapy delivered in a moderately hypofractionated scheme consisting in 15 fractions of 2.7 Gy over 3 weeks. The total prescribed dose will be 40.5 Gy.
3 to 4 weeks after the last radiotherapy session, patients will undergo an MRI scan.
Tumor resection will be performed 4 to 8 weeks after the radiotherapy. A blood sample will be taken prior to this surgery for translational research.
Patients will then be followed up every 4 months for the first 2 years, every 6 months for 3 years and then annually until the end of the study. At each follow up, a clinical examination, an MRI scan and the completion of the MSTS and QLQ-C30/F17 questionnaires will be performed.
The study is planned to end 5 years after the last inclusion. The security and efficacy of the experimental treatment will be assessed. The main analysis will focus on the cumulative incidence of local progressive disease or recurrence at the two-year follow-up.
It is expected that 90% of patients are free of local progression or recurrence at two years in this population and with different radiotherapy regimen. A proportion of patients free from local progression or recurrence at two years of 90% or less will be considered insufficient (p0 = 90%). The alternative hypothesis under consideration is p1 = 95%.
- Conditions
- Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma of the Limb
- Being tested
- Moderately hypofractionated neoadjuvant radiotherapy
- Keywords
- Sarcoma, Trunk, Limb, Radiotherapy, Neoadjuvant
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately hypofractionated neoadjuvant radiotherapyRadiation
Intensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiotherapy | Experimental | Neoadjuvant radiotherapy as described in the "intervention description" field, followed by a tumor resection 4 to 8 after the last session of radiotherapy. Receives: Radiation: Moderately hypofractionated neoadjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control of the disease at the two-year follow-up
Local control of the disease will be assessed by cumulative incidence of local progression / recurrence. The main primary outcome analysis will focus on this incidence at the two-year follow-up.
The cumulative incidence of local progression / recurrence will be estimated by considering the time between the start of radiotherapy and the date of local progression / recurrence.
For patients who are free of local progression / recurrence, this time will be censored at the last follow-up.
Death without prior local progression / recurrence and metastatic progression / recurrence without prior local progression / recurrence will be considered competing events.
Pre-operative tumor assessment will be performed according to the RECIST 1.1 criteria. For the main analysis, a progressive disease according to RECIST 1.1 criteria during or at the end of radiotherapy will not be considered as an event if the patient remains eligible for surgical resection.
Measured: From enrollment to the two-year follow-up
Secondary outcomes (12)
Control of the disease at the two-year follow-up
Recurrence-free survival will be defined as the time between the start of radiotherapy and the date of progression / recurrence (local or metastatic) or death, whatever the cause. Observations of patients who were alive and free of progression / recurrence at the last follow up will be censored at that date.
The three components of recurrence-free survival will be described: cumulative incidence of local progression / recurrence as described in the primary outcome, cumulative incidence of metastatic recurrence (time between the start of radiotherapy and the date of metastatic progression / recurrence), and cumulative incidence of death without prior progression / recurrence (time between the start of radiotherapy and the date of death without prior progression / recurrence).
Measured: From enrollment to the end of study, planned 5 years after the last enrollment
Local control of the disease at the two-year follow-up - sensitivity analysis
Local control of the disease will be assessed as described in the main primary outcome but:
- For the first sensitivity analysis, metastatic progression / recurrence prior to local progression will not be considered a competing event.
- For the second sensitivity analysis, a progressive disease according to RECIST 1.1 criteria during or at the end of radiotherapy will be considered as an event even if the patient remains eligible for surgical resection.
Measured: From enrollment to the two-year follow-up
Overall survival
Overall survival will be defined as the time between the start of radiotherapy and the date of death, regardless of the cause. Patients who are alive at the last study follow-up will be consored at that date.
Measured: From enrollment to the end of study, planned 5 years after the last enrollment
Incidence of amputation
The incidence of amputation will be defined as the time between the start of radiotherapy and the date of amputation regardless of the cause (progressive disease/recurrence, severe trophic complications, ...). Patients who were alive and free of amputation at the last follow-up will be censored at that date. Death without prior amputation will be considered as a competing event. Local or metastatic progression/recurrence will not be considered as a competing event.
Measured: From enrollment to the end of study, planned 5 years after the last enrollment
Radiological response
The radiological response to radiotherapy will assessed by comparing the post-radiotherapy MRI with the Baseline MRI according to the RECIST 1.1 criteria. The objective response will be defined as complete or partial response.
Measured: From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.
Tumor necrosis
The percentage of tumor necrosis will be assessed on Baseline and post-radiotherapy MRI (using the larger slice plan).
Measured: From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.
Histological response
The histological response to radiotherapy will be assessed by determining the percentage of residual tumor in the resected specimen.
Complete necrosis (<5% residual tumor) will be distinguished. The percentage of hyalinisation, necrosis and fibrosis will also be assessed.
Measured: From enrollment to the surgery planned 6 +/- 2 weeks after the end of radiotherapy.
Quality of tumor resection
The quality of tumor resection will be described regardless of the completeness of the resection. A complete tumor resection with histological confirmation of completeness and healthy margin will be described as "R0" ; A complete tumor resection with margin that may contain tumor will be described as "R1" ; Incomplete surgery will be described as "R2".
Measured: From enrollment to surgery planned 6 +/- 2 weekds after the end of the radiotherapy
Morbidity
The morbidity of treatments will be described using the NCI CTCAE v6.0 scale. This will include radiotherapy-related toxicity, from the first session of radiotherapy to the end of the study follow-up, surgical complication from the surgery to the end of the study follow-up, duration of hospitalisation, surgical reoperation, new hospitalisation for surgical complication and time to healing, during the entire study follow-up.
Measured: From enrollment to the end of study, planned 5 years after the last enrollment
Limb function
Limb function will be assessed using the Musculoskeletal Tumor Society (MSTS). This questionnaire will be completed at registration, every 4 months for 2 years, then every 6 months for 3 years.
Measured: From enrollment to the 5 years follow-up
Quality of life with EORTC QLQ-C30 questionnaires
The quality of life will be assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 will be completed at registration, and at the first follow-up planned 4 months after the surgery.
Measured: From enrollment to the 4 months follow-up
Quality of life with EORTC QLQ-F17 questionnaires
The quality of life will be assessed using the EORTC QLQ-F17 questionnaires. During the follow-up, the QLQ-F17 will be completed every 4 months for 2 years, then every 6 months for 3 years.
Measured: From the first follow-up to the 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start21 Jul 2026
- Primary completion1 Jun 2032 (estimated)
- Study completion1 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies 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
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Canther, Lille, Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France
- Responsible party
- Sponsor
- Investigators
- Abel CORDOBA, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507773
- Sponsor's protocol ID
- NEORASARC-2502
- Other IDs
- 2025-A02053-46
- Acronym
- NEORASARC
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial Assessing the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall, Incorporating Translationnal Research
- ClinicalTrials.gov ID
- NCT07507773
- Acronym / sponsor ID
- NEORASARC / NEORASARC-2502
- Conditions
- Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma of the Limb
- Keywords
- Sarcoma, Trunk, Limb, Radiotherapy, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Canther, Lille, Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 1 Jun 2032 (estimated)
- Study completion
- 1 Jun 2035 (estimated)
- First posted
- 2 Apr 2026 (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 trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall. The primary outcome is local disease control, assessed by the cumulative incidence of progression/recurrence.
After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed followed by the experimental treatment: intensity-modulated radiotherapy with a moderately hypofractionated regimen consisting in 15 fractions of 2.7 Gy administered over 3 weeks.
a follow-up assessment will be performed 3 to 4 weeks after the last radiotherapy session.
Tumor resection will be performed 4 to 8 weeks after the radiotherapy. Patients will then be followed up until the end of the study; planned 5 years after the last inclusion.
Radiotherapy will be evaluated in terms of safety and efficacy.
Detailed description
The NEORASARC clinical trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall.
After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed 8 weeks prior to the start of experimental treatment. This baseline assessment will consist in of a clinical examination, an MRI scan, and the completion of the MSTS and QLQ-C30 questionnaires. After a blood sample has been taken for translational research, the patient will receive the experimental treatment : intensity-modulated radiotherapy delivered in a moderately hypofractionated scheme consisting in 15 fractions of 2.7 Gy over 3 weeks. The total prescribed dose will be 40.5 Gy.
3 to 4 weeks after the last radiotherapy session, patients will undergo an MRI scan.
Tumor resection will be performed 4 to 8 weeks after the radiotherapy. A blood sample will be taken prior to this surgery for translational research.
Patients will then be followed up every 4 months for the first 2 years, every 6 months for 3 years and then annually until the end of the study. At each follow up, a clinical examination, an MRI scan and the completion of the MSTS and QLQ-C30/F17 questionnaires will be performed.
The study is planned to end 5 years after the last inclusion. The security and efficacy of the experimental treatment will be assessed. The main analysis will focus on the cumulative incidence of local progressive disease or recurrence at the two-year follow-up.
It is expected that 90% of patients are free of local progression or recurrence at two years in this population and with different radiotherapy regimen. A proportion of patients free from local progression or recurrence at two years of 90% or less will be considered insufficient (p0 = 90%). The alternative hypothesis under consideration is p1 = 95%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant radiotherapy | Experimental | Radiation: Moderately hypofractionated neoadjuvant radiotherapyNeoadjuvant radiotherapy as described in the "intervention description" field, followed by a tumor resection 4 to 8 after the last session of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged ≥ 18 years ;
- Localised sarcoma of a limb, the root of a limb, or the trunk wall ;
- Histologically confirmed diagnosis of soft tissue sarcoma regardless of the grade ;
- Diagnosis biopsy performed at Centre Oscar Lambret, with specimen available for translational research ;
- Indication of neoadjuvant radiotherapy according to the multidisciplinary consultation meeting ;
Key exclusion criteria (8 listed)
- Metastatic disease (including local lymph node diffusion) ;
- Visceral or retroperitoneal sarcoma ;
- Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;
- Indication of neoadjuvant or adjuvant chemotherapy ;
- Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;
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 |
|---|---|---|
| Moderately hypofractionated neoadjuvant radiotherapyIntensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks. | Radiation | Neoadjuvant radiotherapy |
Primary outcome
Local control of the disease at the two-year follow-up
Time frame: From enrollment to the two-year follow-up
Local control of the disease will be assessed by cumulative incidence of local progression / recurrence. The main primary outcome analysis will focus on this incidence at the two-year follow-up. The cumulative incidence of local progression / recurrence will be estimated by considering the time between the start of radiotherapy and the date of local progression / recurrence. For patients who are free of local progression / recurrence, this time will be censored at the last follow-up. Death without prior local progression / recurrence and metastatic progression / recurrence without prior local progression / recurrence will be considered competing events. Pre-operative tumor assessment will be performed according to the RECIST 1.1 criteria. For the main analysis, a progressive disease according to RECIST 1.1 criteria during or at the end of radiotherapy will not be considered as an event if the patient remains eligible for surgical resection.
12 secondary outcomes
Control of the disease at the two-year follow-up
Time frame: From enrollment to the end of study, planned 5 years after the last enrollment
Local control of the disease at the two-year follow-up - sensitivity analysis
Time frame: From enrollment to the two-year follow-up
Overall survival
Time frame: From enrollment to the end of study, planned 5 years after the last enrollment
Incidence of amputation
Time frame: From enrollment to the end of study, planned 5 years after the last enrollment
Radiological response
Time frame: From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.
Tumor necrosis
Time frame: From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.
Histological response
Time frame: From enrollment to the surgery planned 6 +/- 2 weeks after the end of radiotherapy.
Quality of tumor resection
Time frame: From enrollment to surgery planned 6 +/- 2 weekds after the end of the radiotherapy
Morbidity
Time frame: From enrollment to the end of study, planned 5 years after the last enrollment
Limb function
Time frame: From enrollment to the 5 years follow-up
Quality of life with EORTC QLQ-C30 questionnaires
Time frame: From enrollment to the 4 months follow-up
Quality of life with EORTC QLQ-F17 questionnaires
Time frame: From the first follow-up to the 5 years follow-up
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 23 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Abel CORDOBA, MD principal investigator
Centre Oscar Lambret
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 Moderately hypofractionated neoadjuvant radiotherapy in people with Soft Tissue Sarcoma Adult and Soft Tissue Sarcoma (Excluding GIST), run by Centre Oscar Lambret 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 8 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 23 Jul 2026. 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 Julien THERY ((0)320295918 ext. +33, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control of the disease at the two-year follow-up (time frame: From enrollment to the two-year follow-up). 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 23 Jul 2026.