Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas
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: Administration of L-TC, HFRT alone.
- Who it may be relevant to
- Registry conditions: Sarcoma. 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 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas
Overview
This is phase II randomized, multicenter study of treatment with L-TC and preoperative HFRT in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity. Eligible patients will be randomly assigned 2:1 to receive a preoperative HFRT alone (Arm A) or L-TC with preoperative HFRT (Arm B).
Detailed description
This is a non-comparative phase II trial (comparison is made regarding a reference, not 2 between 2 proportions). Considering the wide confidence interval retrieved in literature regarding pCR value with HFRT, pCR value used in the sample size calculation and taken from the literature must be included in the 95% CI of the pCR from the control group.
The PRACTISS trial aims to improve treatment outcomes for patients with extremity STS by incorporating Liposomal Transcrocetin (L-TC) with Hypofractionated Radiotherapy (HFRT). L-TC is designed to enhance tumor oxygenation, addressing hypoxia-a significant factor contributing to radioresistance. By reoxygenating tumor cells, L-TC may improve radiosensitivity, increasing the efficacy of radiotherapy and leading to higher rates of pathological complete response (pCR) before surgery. Achieving a higher pCR is associated with better long-term outcomes and reduced recurrence rates. Additionally, the use of HFRT reduces the overall treatment schedule compared to conventional radiotherapy, minimizing the treatment burden for patients and potentially improving their quality of life while maintaining treatment effectiveness.
L-TC 300 mg QD, administered as intravenous infusion over 90 minutes, at a fixed dose of 300 mg daily before each HFRT fraction, for a total of 5 days corresponding to the planned five daily HFRT fractions. The intravenous infusion should start 120 minutes before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion
Interventions
- Drug Administration of L-TC
Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session - Radiation HFRT alone
HFRT : 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
Primary outcome measures
- Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT) [Time frame: At surgery (Between 4 and 8 weeks after the end of radiotherapy)]
Secondary outcome measures (11)
- Evaluation of the acute tolerance o f L-TC [Time frame: Up to day 5 (every day during the treatment)]
- Evaluation of the late tolerance o f L-TC [Time frame: Up to day 28 after the end of treatment.]
- Evaluation of the acute tolerance of radiotherapy [Time frame: Up to day 5 (every day during the treatment)]
- Evaluation of the late tolerance of radiotherapy [Time frame: at 4 months after surgery, and at 12, 18, 24, 36 and 60 months]
- Evaluation of tumour necrosis [Time frame: At surgery (Between 4 and 8 weeks after the end of radiotherapy)]
- Evaluation of the radiological response [Time frame: at screening and before surgery]
- Proportion of patients with R0 resection [Time frame: At surgery]
- Evaluation of the Local Progression-Free Survival (L-PFS) [Time frame: at 12, 24, 36 and 60 months.]
- Evaluation of the Distant Progression-Free Survival (D-PFS) [Time frame: at 12, 24, 36 and 60 months.]
- Evaluation of the Overall Survival (OS) [Time frame: at 12, 24, 36 and 60 months]
- Evaluation of the Quality of Life (QoL) [Time frame: at the inclusion (baseline) and every 4 months the two first years and then every 6 months the next three years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Localized or locally advanced soft tissue sarcoma of extremity proven by biopsy histological grade 2 and 3.
- Pathological expert proof-reading in reference centers
- HFRT and surgery planned (regardless the potential inclusion in this trial) as decided in a multidisciplinary tumor board, in reference centre (European Society for Medical Oncology (ESMO) guideline 2021)
- R0 surgery is feasible, in reference centers
- Pre-biopsy MRI available
- Performance status of 0-2 and life expectancy of at least 6 months
Exclusion criteria
- Patient who cannot undergo MRI
- Patients with localized or locally advanced soft tissue sarcoma of extremity proven by biopsy with histological grade 1
- Previous radiation in the area
- Woman who is pregnant or breastfeeding
- Soft tissue sarcoma developed in irradiated area.
- Patients with myxoid liposarcoma, embryonal or alveolar rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, angiosarcoma, primitive neuroectodermal tumor, desmoid-type fibromatosis, or dermatofibrosarcoma protuberans
- Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- CGFL — Dijon
- ICANS — Strasbourg
Identifiers
NCT: NCT06476704 · 2020-016 · 2024-515668-30-00