Glioblastoma Multiforme, AdultPhase 2SIB-DOPANCT05653622
Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma
A Phase 2 study testing Integrated boost technique (SIB) guided by PET FDOPA in people with Glioblastoma Multiforme, Adult, run by Centre Paul Strauss at 3 sites in France.
Trial summary
Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Adult
- What is being tested?
- Integrated boost technique (SIB) guided by PET FDOPA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Jun 2025to 1 Jul 2029
- 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
- Unfit patient without indication to the STUPP protocol :
- Cohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients > 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available
- Histologically proven glioblastoma
- Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)
Who cannot join
- Patients with an indication for irradiation according to the STUPP protocol (fit patient)
- Patient with a contraindication to MRI or PET
- Limit of the provisional target volume or Planning target volume (PTV), second PTV < 2 cm from the chiasm and the optic nerves
- Absence of uptake of FDopa
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHRU de Nancy
Nancy, De, 5400
Luc TAILLANDIER, Pr, l.taillandier@chru-nancy.fr
Luc TAILLANDIER, Pr
- Recruiting
Centre Paul Strauss
Strasbourg
Caroline BUND, 0368766767, c.bund@institut-strauss.fr
Caroline BUND
- Recruiting
ICL
Vandœuvre-lès-Nancy
Nicolas DEMOGEOT, 03 83 59 85 74, n.demogeot@nancy.unicancer.fr
Nicolas DEMOGEOT, MD
About this study
Official title: Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma
Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months.
Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ. For some, the radiation dose is not optimal. Moreover, recurrences develop mainly in the initial tumor site. These two reasons justify increasing the dose. To limit the movements of these fragile patients, the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost (SIB) which increases the dose in targeted volumes while the rest of the volume receives a minimum dose. A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI.
Read more
FDOPA PET detects certain more aggressive tumor areas, areas likely to recur. Integrating them into the SIB seems appropriate. A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS. This study differed from the one the investigators propose, because a dose and conventional fractionation, identical to that of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (NCIC/EORTC) protocol were delivered, the gliomas were unmethylated MGMT, less likely to respond. Studies with SIB and hypofractionation are often retrospective and for others, hypofractionation was debatable and the dose increase was not based on PET capture but on MRI. However, a prospective phase II study, with SIB and hypofractionation, not integrating FDopa PET has demonstrated the relevance of SIB.
In this project, the investigators propose to use the integrated boost technique (SIB) guided by PET FDOPA to increase the radiation dose in GBM, in patients either fragile and partially operated, or only biopsied and for whom the prognosis is the most pejorative.
- Conditions
- Glioblastoma Multiforme, Adult
- Being tested
- Integrated boost technique (SIB) guided by PET FDOPA
- Keywords
- glioblastoma, intensity modulated radiation therapy, 18F-DOPA-PET imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated boost technique (SIB) guided by PET FDOPAProcedure or surgery
intensity-modulated irradiation scheme with integrated boost technique (SIB) guided by PET FDOPA during the chemo-radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| SIB-DOPA | Experimental | Not described Receives: Procedure: Integrated boost technique (SIB) guided by PET FDOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Evaluate the overall survival (OS) of patients with glioblastoma treated with integrated boost (SIB) with increased dose guided by FDOPA PET
Measured: At 24 months after inclusion
Secondary outcomes (18)
Progression-Free Survival (PFS)
To assess the progression-free survival (PFS) of patients with glioblastoma treated with SIB with increased dose guided by FDOPA PET
Measured: At 24 months after inclusion
Sites of progression: distant, marginal or in-field progression
The progression will be defined by its location by comparing the progression imaging with that used for dosimetry. It will be considered "distant" if it develops beyond the 95% isodose, "marginal" if it cuts the 95% isodose and "in-field" if it is completely within the 95% isodose. The 95% isodose is the reference isodose for the prescription of hypofractionated radiotherapy.
Measured: At the date of progression, assessed up to 24 months
Assess the rate of acute complications of grade ≥ 3
Acute toxicities are defined as toxicities by the Common Terminology Criteria for Adverse Events (CTCAE v5) occurring within 6 months of the start of radiotherapy.
Measured: At 6 months after the start of radiotherapy
Characterize the PET parameters during progression
PET Parameters:
- Standardized Uptake Value (SUV) max tumor, SUV max tumor/healthy tissue, SUV max T/striatum
- SUV mean tumor, SUV mean tumor/healthy tissue, SUV mean T/striatum
Measured: At the date of progression, assessed up to 24 months
Evolution of the PET parameters
PET Parameters:
- Standardized Uptake Value (SUV) max tumor, SUV max tumor/healthy tissue, SUV max T/striatum
- SUV mean tumor, SUV mean tumor/healthy tissue, SUV mean T/striatum
Measured: Change between baseline and the date of progression, assessed up to 24 months
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
The quality of life will be measured at the inclusion with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
The quality of life will be measured at the inclusion with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
The quality of life will be measured at 3 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 3 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
The quality of life will be measured at 3 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 3 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
The quality of life will be measured at 6 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 6 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
The quality of life will be measured at 6 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 6 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
The quality of life will be measured at 12 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 12 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
The quality of life will be measured at 12 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 12 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
The quality of life will be measured at 18 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 18 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
The quality of life will be measured at 18 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At 18 months after inclusion
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Overall survival
MGMT promoter methylation status (binary variable, determined by either Polymerase Chain reaction (PCR) or immunohistochemistry)
Measured: At 24 months after inclusion
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Progression-Free Survival
MGMT promoter methylation status (binary variable, determined by either PCR or immunohistochemistry)
Measured: At 24 months after inclusion
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and acute toxicities
MGMT promoter methylation status (binary variable, determined by either PCR or immunohistochemistry)
Measured: At 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start23 Jun 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma Multiforme, 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline BUND, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653622
- Sponsor's protocol ID
- 2021-010
- Acronym
- SIB-DOPA
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, Fay M, Nishikawa R, Cairncross JG, Roa W, Osoba D, Rossiter JP, Sahgal A, Hirte H, Laigle-Donadey F, Franceschi E, Chinot O, Golfinopoulos V, Fariselli L, Wick A, Feuvret L, Back M, Tills M, Winch C, Baumert BG, Wick W, Ding K, Mason WP; Trial Investigators. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. N Engl J Med. 2017 Mar 16;376(11):1027-1037. doi: 10.1056/NEJMoa1611977.
PubMed 28296618Truc G, Bernier V, Mirjolet C, Dalban C, Mazoyer F, Bonnetain F, Blanchard N, Lagneau E, Maingon P, Noel G. A phase I dose escalation study using simultaneous integrated-boost IMRT with temozolomide in patients with unifocal glioblastoma. Cancer Radiother. 2016 May;20(3):193-8. doi: 10.1016/j.canrad.2015.12.005. Epub 2016 Apr 23.
PubMed 27117900Somme F, Bender L, Namer IJ, Noel G, Bund C. Usefulness of 18F-FDOPA PET for the management of primary brain tumors: a systematic review of the literature. Cancer Imaging. 2020 Oct 6;20(1):70. doi: 10.1186/s40644-020-00348-5.
PubMed 33023662
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma
- ClinicalTrials.gov ID
- NCT05653622
- Acronym / sponsor ID
- SIB-DOPA / 2021-010
- Conditions
- Glioblastoma Multiforme, Adult
- Keywords
- glioblastoma, intensity modulated radiation therapy, 18F-DOPA-PET imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 16 Dec 2022 (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.
Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months.
Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ. For some, the radiation dose is not optimal. Moreover, recurrences develop mainly in the initial tumor site. These two reasons justify increasing the dose. To limit the movements of these fragile patients, the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost (SIB) which increases the dose in targeted volumes while the rest of the volume receives a minimum dose. A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI.
FDOPA PET detects certain more aggressive tumor areas, areas likely to recur. Integrating them into the SIB seems appropriate. A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS. This study differed from the one the investigators propose, because a dose and conventional fractionation, identical to that of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (NCIC/EORTC) protocol were delivered, the gliomas were unmethylated MGMT, less likely to respond. Studies with SIB and hypofractionation are often retrospective and for others, hypofractionation was debatable and the dose increase was not based on PET capture but on MRI. However, a prospective phase II study, with SIB and hypofractionation, not integrating FDopa PET has demonstrated the relevance of SIB.
In this project, the investigators propose to use the integrated boost technique (SIB) guided by PET FDOPA to increase the radiation dose in GBM, in patients either fragile and partially operated, or only biopsied and for whom the prognosis is the most pejorative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIB-DOPA | Experimental | Procedure: Integrated boost technique (SIB) guided by PET FDOPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unfit patient without indication to the STUPP protocol :
- Cohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients > 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available
- Histologically proven glioblastoma
- Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)
Key exclusion criteria (4 listed)
- Patients with an indication for irradiation according to the STUPP protocol (fit patient)
- Patient with a contraindication to MRI or PET
- Limit of the provisional target volume or Planning target volume (PTV), second PTV < 2 cm from the chiasm and the optic nerves
- Absence of uptake of FDopa
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 |
|---|---|---|
| Integrated boost technique (SIB) guided by PET FDOPAintensity-modulated irradiation scheme with integrated boost technique (SIB) guided by PET FDOPA during the chemo-radiotherapy | Procedure or surgery | SIB-DOPA |
Primary outcome
Overall Survival (OS)
Time frame: At 24 months after inclusion
Evaluate the overall survival (OS) of patients with glioblastoma treated with integrated boost (SIB) with increased dose guided by FDOPA PET
18 secondary outcomes
Progression-Free Survival (PFS)
Time frame: At 24 months after inclusion
Sites of progression: distant, marginal or in-field progression
Time frame: At the date of progression, assessed up to 24 months
Assess the rate of acute complications of grade ≥ 3
Time frame: At 6 months after the start of radiotherapy
Characterize the PET parameters during progression
Time frame: At the date of progression, assessed up to 24 months
Evolution of the PET parameters
Time frame: Change between baseline and the date of progression, assessed up to 24 months
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 3 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 3 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 6 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 6 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 12 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 12 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 18 months after inclusion
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 18 months after inclusion
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Overall survival
Time frame: At 24 months after inclusion
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Progression-Free Survival
Time frame: At 24 months after inclusion
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and acute toxicities
Time frame: At 24 months after inclusion
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 4 Feb 2026.
- Background: PubMed 28296618Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, Fay M, Nishikawa R, Cairncross JG, Roa W, Osoba D, Rossiter JP, Sahgal A, Hirte H, Laigle-Donadey F, Franceschi E, Chinot O, Golfinopoulos V, Fariselli L, Wick A, Feuvret L, Back M, Tills M, Winch C, Baumert BG, Wick W, Ding K, Mason WP; Trial Investigators. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. N Engl J Med. 2017 Mar 16;376(11):1027-1037. doi: 10.1056/NEJMoa1611977.
- Background: PubMed 27117900Truc G, Bernier V, Mirjolet C, Dalban C, Mazoyer F, Bonnetain F, Blanchard N, Lagneau E, Maingon P, Noel G. A phase I dose escalation study using simultaneous integrated-boost IMRT with temozolomide in patients with unifocal glioblastoma. Cancer Radiother. 2016 May;20(3):193-8. doi: 10.1016/j.canrad.2015.12.005. Epub 2016 Apr 23.
- Background: PubMed 33023662Somme F, Bender L, Namer IJ, Noel G, Bund C. Usefulness of 18F-FDOPA PET for the management of primary brain tumors: a systematic review of the literature. Cancer Imaging. 2020 Oct 6;20(1):70. doi: 10.1186/s40644-020-00348-5.
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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.
Caroline BUND principal investigator
Centre Paul Strauss
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Integrated boost technique (SIB) guided by PET FDOPA in people with Glioblastoma Multiforme, Adult, run by Centre Paul Strauss at 3 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 4 inclusion and 4 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Anne ANTHONY (+33(0)388252413, promotion-rc@institut-strauss.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: At 24 months after inclusion). 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 NCT05653622, which also lists 3 linked publications.
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 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.