GlioblastomaPhase 2ReciDOPANCT05653635
Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
A Phase 2 study testing Simultaneous-integrated boost with IMRT in people with Glioblastoma, run by Centre Paul Strauss at 2 sites in France.
Trial summary
ReciDOPA is a phase II, single-stage randomized, multicenter, prospective trial assessing the efficacy of an irradiation protocol based on Intensity-modulated radiation therapy with simultaneous-integrated boost guided by FDOPA-PET in patient with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Simultaneous-integrated boost with IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2026to 1 Sep 2028
- 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
- Glioblastoma, World Health Organization (WHO) grade IV, histologically proven
- Performance status 0, 1 or 2
- Neurological status ≥ 2
- Past irradiation in previsional re-irradiated site or in the vicinity (5 to 7 cm)
- Radiological proven recurrence according to 1 and 2 criteria, Wen et al
Show all 10Show fewer
- Remaining node after partial surgery post-recurrence
- 1 to 3 recurrence site(s) < 35 mm in wide axis and separated by at least 5 mm
- Volume of each lesion < 35 mL
- Distance between recurrence node(s) and optic nerves (left and right), chiasma and/or cerebral trunk > 10 mm
Who cannot join
- Patient with contraindication to MRI or PET
- Glioblastomatose
- Pregnancy or breastfeeding
- Patient that do not understand French
- Patient without affiliation to the national or local social security
- Patients not able to comply to the protocol assessments for geographic, social or psychological reasons
Show all 10Show fewer
- Minor or patients placed under guardianship or supervision
- Patients deprived of liberty
- Patients placed under judicial protection
- Patients that are not able to express their consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
CHRU de Nancy
Nancy, De, 5400
Luc TAILLANDIER, Pr, l.taillandier@chru-nancy.fr
Luc TAILLANDIER, Pr
- Recruiting
Centre Paul Strauss
Strasbourg, 67033
Clara LE FEVRE, MD, promotion-rc@institut-strauss.fr
Clara LE FEVRE, MD
About this study
ReciDOPA is a phase II, single-stage randomized, multicenter, prospective trial assessing the efficacy of an irradiation protocol based on Intensity-modulated radiation therapy with simultaneous-integrated boost guided by FDOPA-PET in patient with recurrent glioblastoma.
Read the detailed description
Glioblastoma (GBM) is the most common cerebral tumor in adults. Despite well-conducted treatments including surgery, chemo-radiotherapy and chemotherapy according to the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) protocol, recurrences remain unavoidable within approximately 6 months and the overall survival rate of patients at 5 years is inferior to 10%.
In case of recurrence, a second surgery, radiotherapy under stereotaxic conditions, bevacizumab or other innovative techniques have been proposed. However, they are not yet considered as reference treatments, due to the absence of therapeutic trials definitively proving their efficacy.
Evaluation of GBM progression is based on MRI, corticosteroid intake and clinical status.However, positron emission tomography (PET) is an extremely relevant examination for differentiating between true progression and pseudo-progression. Indeed, an increase in the transfer of amino acids in 18 F-dihydroxyphenylalanine (FDOPA)-PET strongly suggests a recurrence. A local treatment can then be proposed by favoring surgery or, as an option, radiotherapy under stereotactic conditions. However, this treatment, even if it is well tolerated, has an efficacy which could be improved.
Often proposed option to improve efficacy of this radiation technic consists in increasing the dose of irradiation. This dose increase is often limited by the tolerance of nearby healthy tissue. It could however be possible with coupled techniques of intensity modulation and stereotaxy within the framework of an integrated boost (Simultaneous Integrated Boost - SIB). At each radiation session, the dose delivered to the tumor volume would be increased in the metabolic volume (BTV) detected by FDOPA-PET.
The objective of this study is to evaluate, in patients with recurrent glioblastoma, the efficacy of a dose increase using an SIB in a volume delineated with FDOPA-PET.
- Conditions
- Glioblastoma
- Being tested
- Simultaneous-integrated boost with IMRT
- Keywords
- Glioblastoma, Simultaneous Integrated Boost
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous-integrated boost with IMRTRadiation
Simultaneous-integrated boost guided by FDOPA-PET
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT) | Experimental | * Planning Target Volume (PTV) 37,5 Gray (Gy): 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days
* Prescription isodose line (PIL) at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction
* PTV SIB 45 Gy: 45,0 Gy in 6 fractions of 7,50 Gy at the rate of one fraction each 2 days
* PIL at 80% corresponding to 36 Gy as total dose, or 6 Gy per fraction Receives: Radiation: Simultaneous-integrated boost with IMRT |
| Standard IMRT | No intervention | * PTV 37,5 Gy: 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days * PIL at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction * No SIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma
Recurrence free survival: interval between the date of inclusion in the trial until the date of recurrence of irradiated site (or one of the irradiated sites, in case of multiple irradiation)
Measured: up to 24 months
Secondary outcomes (17)
Percentage of recurrence of irradiated sites
Number of sites with recurrence over the number of irradiated sites
Measured: up to 24 months
Characterization of recurrence sites: classified either as distant, marginal or in-field
Recurrence will be described according to their localisation by comparing images at recurrence with the images used for dosimetry. A recurrence will be defined as " distant" is it appears outside of 80% isodose, as "marginal" if it cuts 80% isodose and as "in-field" if it is completely located in 80% isodose. The 80% isodose is the reference isodose used for radiation therapy prescription.
Measured: up to 24 months
Percentage of Recurrence free survival at 6 months
Interval between the date of inclusion in the trial until the date of recurrence of irradiated site (first recurrence, in case of multiple irradiation). Patients that are alive without recurrence at the end of the tiral will be censored
Measured: At 6 months
Percentage of Recurrence free survival at 12 months
Interval between the date of inclusion in the trial until the date of recurrence of irradiated site (first recurrence, in case of multiple irradiation). Patients that are alive without recurrence at the end of the tiral will be censored
Measured: at 12 months
Overall survival
Interval between the date of inclusion in the trial until the date of death whatever the cause. Patients that are alive without recurrence at the end of the tiral will be censored
Measured: From date of inclusion until the date of death from any cause, assessed up to 72 months
Tolerance of re-irradiation
Recording of toxicities (according to Common Terminology Criteria for Adverse Events v5 criteria) at each follow-up visit
Measured: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV max value
Standardized Uptake Value (SUV) max
Measured: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value
SUV mean
Measured: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value
SUV peak
Measured: up to 24 months
Quality of Life at 2 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Quality of life will be measure with the 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 2 months
Quality of Life at 2 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Quality of life will be measured 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 2 months
Quality of Life at 4 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Quality of life will be measure with the 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 4 months
Quality of Life at 4 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Quality of life will be measured 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 4 months
Quality of Life at 6 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Quality of life will be measure with the 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
Quality of Life at 6 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Quality of life will be measured 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
Quality of Life at 12 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Quality of life will be measure with the 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
Quality of Life at 12 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Quality of life will be measured 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
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 start1 Mar 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Georges François Leclerc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653635
- Sponsor's protocol ID
- 2021-011
- Acronym
- ReciDOPA
- 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
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
- Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT05653635
- Acronym / sponsor ID
- ReciDOPA / 2021-011
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Simultaneous Integrated Boost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Collaborators
- Centre Georges François Leclerc
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (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.
ReciDOPA is a phase II, single-stage randomized, multicenter, prospective trial assessing the efficacy of an irradiation protocol based on Intensity-modulated radiation therapy with simultaneous-integrated boost guided by FDOPA-PET in patient with recurrent glioblastoma.
Detailed description
Glioblastoma (GBM) is the most common cerebral tumor in adults. Despite well-conducted treatments including surgery, chemo-radiotherapy and chemotherapy according to the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) protocol, recurrences remain unavoidable within approximately 6 months and the overall survival rate of patients at 5 years is inferior to 10%.
In case of recurrence, a second surgery, radiotherapy under stereotaxic conditions, bevacizumab or other innovative techniques have been proposed. However, they are not yet considered as reference treatments, due to the absence of therapeutic trials definitively proving their efficacy.
Evaluation of GBM progression is based on MRI, corticosteroid intake and clinical status.However, positron emission tomography (PET) is an extremely relevant examination for differentiating between true progression and pseudo-progression. Indeed, an increase in the transfer of amino acids in 18 F-dihydroxyphenylalanine (FDOPA)-PET strongly suggests a recurrence. A local treatment can then be proposed by favoring surgery or, as an option, radiotherapy under stereotactic conditions. However, this treatment, even if it is well tolerated, has an efficacy which could be improved.
Often proposed option to improve efficacy of this radiation technic consists in increasing the dose of irradiation. This dose increase is often limited by the tolerance of nearby healthy tissue. It could however be possible with coupled techniques of intensity modulation and stereotaxy within the framework of an integrated boost (Simultaneous Integrated Boost - SIB). At each radiation session, the dose delivered to the tumor volume would be increased in the metabolic volume (BTV) detected by FDOPA-PET.
The objective of this study is to evaluate, in patients with recurrent glioblastoma, the efficacy of a dose increase using an SIB in a volume delineated with FDOPA-PET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT) | Experimental | Radiation: Simultaneous-integrated boost with IMRT* Planning Target Volume (PTV) 37,5 Gray (Gy): 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days * Prescription isodose line (PIL) at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction * PTV SIB 45 Gy: 45,0 Gy in 6 fractions of 7,50 Gy at the rate of one fraction each 2 days * PIL at 80% corresponding to 36 Gy as total dose, or 6 Gy per fraction |
| Standard IMRT | No intervention | –* PTV 37,5 Gy: 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days * PIL at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction * No SIB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years
- Glioblastoma, World Health Organization (WHO) grade IV, histologically proven
- Performance status 0, 1 or 2
- Neurological status ≥ 2
- Past irradiation in previsional re-irradiated site or in the vicinity (5 to 7 cm)
Key exclusion criteria (10 listed)
- Patient with contraindication to MRI or PET
- Glioblastomatose
- Pregnancy or breastfeeding
- Patient that do not understand French
- Patient without affiliation to the national or local social security
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 |
|---|---|---|
| Simultaneous-integrated boost with IMRTSimultaneous-integrated boost guided by FDOPA-PET | Radiation | Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT) |
Primary outcome
Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma
Time frame: up to 24 months
Recurrence free survival: interval between the date of inclusion in the trial until the date of recurrence of irradiated site (or one of the irradiated sites, in case of multiple irradiation)
17 secondary outcomes
Percentage of recurrence of irradiated sites
Time frame: up to 24 months
Characterization of recurrence sites: classified either as distant, marginal or in-field
Time frame: up to 24 months
Percentage of Recurrence free survival at 6 months
Time frame: At 6 months
Percentage of Recurrence free survival at 12 months
Time frame: at 12 months
Overall survival
Time frame: From date of inclusion until the date of death from any cause, assessed up to 72 months
Tolerance of re-irradiation
Time frame: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV max value
Time frame: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value
Time frame: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value
Time frame: up to 24 months
Quality of Life at 2 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 2 months
Quality of Life at 2 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 2 months
Quality of Life at 4 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 4 months
Quality of Life at 4 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 4 months
Quality of Life at 6 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 6 months
Quality of Life at 6 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 6 months
Quality of Life at 12 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
Time frame: At 12 months
Quality of Life at 12 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
Time frame: At 12 months
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.
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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.
2 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 Simultaneous-integrated boost with IMRT in people with Glioblastoma, 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 10 inclusion and 10 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 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 Anne ANTHONY ((0)388252413 ext. 33, 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?
Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.