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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02053-46 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Canther, Lille | UNKNOWN |
| Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France | UNKNOWN |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderately hypofractionated neoadjuvant radiotherapy | Radiation | Intensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the two-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien THERY | Contact | (0)320295918 | +33 | promotion@o-lambret.fr |
| Name | Affiliation | Role |
|---|---|---|
| Abel CORDOBA, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
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| 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:
| 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. | 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. | 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. | 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). | 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. | 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". | 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. | 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. | 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. | 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. | From the first follow-up to the 5 years follow-up |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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