Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderately hypofractionated neoadjuvant radiotherapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma of the Limb. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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%.
Interventions
- Radiation Moderately hypofractionated neoadjuvant radiotherapy
Intensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks.
Primary outcome measures
- Local control of the disease at the two-year follow-up [Time frame: From enrollment to the two-year follow-up]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre Oscar Lambret — Lille
Identifiers
NCT: NCT07507773 · NEORASARC-2502 · 2025-A02053-46