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SarcomaPhase 2PRACTISSNCT06476704

Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas

A Phase 2 study testing Administration of L-TC and HFRT alone in people with Sarcoma, run by Centre Paul Strauss at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
Administration of L-TC and HFRT alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesFrance
Study dates
1 Jul 2026to 1 Jun 2033
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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Manon VOEGELIN contact

368339523 ext. +33

promotion-rc@icans.eu

France2 sites

  • CGFL

    Dijon

    Gilles TRUC, 33380737518, gtruc@cgfl.fr

  • ICANS

    Strasbourg

    Georges NOEL, 33368339523, promotion-rc@icans.eu

Other trials in France

About this study

Official title: Phase 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas

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).

Read the 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

Conditions
Sarcoma
Being tested
Administration of L-TC, HFRT alone
Keywords
hypofractionated radiotherapy, soft tissue sarcoma, hypoxia, liposomal transcrocetin, neo-adjuvant
Medical subject headings
Sarcoma, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of L-TCDrug

    Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session

  • HFRT aloneRadiation

    HFRT : 30 Gy in 5 fractions of 6 Gy.

    1 fraction per day, 5 days per week.

Study groups in NCT06476704
Study groupRoleWhat they receive
Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)ExperimentalL-TC as an IV 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 begin 2 hours before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion. + HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
Receives: Drug: Administration of L-TC
Hypofractionated radiotherapy aloneActive comparatorHFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
Receives: Radiation: HFRT alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT)

    Pathological complete response rate (pCR): defined as the presence of < 10% residual malignant viable cells.

    Measured: At surgery (Between 4 and 8 weeks after the end of radiotherapy)

Secondary outcomes (11)

  1. Evaluation of the acute tolerance o f L-TC

    Toxicities and biological analysis before each injection of L-TC and before surgery, described by type and grade, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 classification

    Measured: Up to day 5 (every day during the treatment)

  2. Evaluation of the late tolerance o f L-TC

    Toxicities and biological analysis before each injection of L-TC and before surgery, described by type and grade, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 classification

    Measured: Up to day 28 after the end of treatment.

  3. Evaluation of the acute tolerance of radiotherapy

    Global tolerance (radiotherapy toxicities (oedema, radiodermatitis, fibrosis, bone fracture) and laboratory abnormalities) at each physician consultation for radiotherapy and at follow-up, using the CTCAE v.5.0 classification

    Measured: Up to day 5 (every day during the treatment)

  4. Evaluation of the late tolerance of radiotherapy

    Global tolerance (radiotherapy toxicities (oedema, radiodermatitis, fibrosis, bone fracture) and laboratory abnormalities) at each physician consultation for radiotherapy and at follow-up, using the CTCAE v.5.0 classification

    Measured: at 4 months after surgery, and at 12, 18, 24, 36 and 60 months

  5. Evaluation of tumour necrosis

    Proportion of patient whom tumor has pathologic necrosis on histologic examination

    Measured: At surgery (Between 4 and 8 weeks after the end of radiotherapy)

  6. Evaluation of the radiological response

    Proportion of patients with a complete or partial radiological response (according to RECIST 1.1) evaluated on MRI

    Measured: at screening and before surgery

  7. Proportion of patients with R0 resection

    Number of patients with R0 resection on the number of enrolled patients

    Measured: At surgery

  8. Evaluation of the Local Progression-Free Survival (L-PFS)

    L-PFS will be defined as the length of time from the date of diagnostic by biopsy to the date of local relapse on MRI.

    L-PFS will be determined in median and rate

    Measured: at 12, 24, 36 and 60 months.

  9. Evaluation of the Distant Progression-Free Survival (D-PFS)

    D-PFS will be defined as the length of time from the date of diagnostic by biopsy to the date of distant relapse on scanner.

    D-PFS will be determined in median and rate

    Measured: at 12, 24, 36 and 60 months.

  10. Evaluation of the Overall Survival (OS)

    OS will be defined as the length of time from the date of diagnostic by biopsy to the date of death, whatever the cause. Patients will be censored on the last news date.

    OS will be determined in median and rate

    Measured: at 12, 24, 36 and 60 months

  11. Evaluation of the Quality of Life (QoL)

    Use of the European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire (QLQ-C30)

    Measured: at the inclusion (baseline) and every 4 months the two first years and then every 6 months the next three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion1 Jun 2033 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476704
Sponsor's protocol ID
2020-016
Other IDs
2024-515668-30-00
Acronym
PRACTISS
Status last verified
Jun 2026
First submitted
21 Jun 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Administration of L-TC and HFRT alone in people with Sarcoma, run by Centre Paul Strauss at 2 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 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 2 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 Manon VOEGELIN (368339523 ext. +33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476704.

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 4 Jun 2026.

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