Clinical trial NCT05653635: Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
Official title: Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Glioblastoma
Simultaneous Integrated Boost
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: Centre Georges François Leclerc
First posted: 2022-12-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma
timeFrame: up to 24 months
Secondary outcomes:
measure: Percentage of recurrence of irradiated sites
timeFrame: up to 24 months
measure: Characterization of recurrence sites: classified either as distant, marginal or in-field
timeFrame: up to 24 months
measure: Percentage of Recurrence free survival at 6 months
timeFrame: At 6 months
measure: Percentage of Recurrence free survival at 12 months
timeFrame: at 12 months
measure: Overall survival
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 72 months
measure: Tolerance of re-irradiation
timeFrame: up to 24 months
measure: Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV max value
timeFrame: up to 24 months
measure: Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value
timeFrame: up to 24 months
measure: Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value
timeFrame: up to 24 months
measure: Quality of Life at 2 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
timeFrame: At 2 months
measure: Quality of Life at 2 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
timeFrame: At 2 months
measure: Quality of Life at 4 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
timeFrame: At 4 months
measure: Quality of Life at 4 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
timeFrame: At 4 months
measure: Quality of Life at 6 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
timeFrame: At 6 months
measure: Quality of Life at 6 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
timeFrame: At 6 months
measure: Quality of Life at 12 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)
timeFrame: At 12 months
measure: Quality of Life at 12 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)
timeFrame: At 12 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References: