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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Simultaneous-integrated boost guided by FDOPA-PET
CHRU de Nancy
Nancy, De, France
NOT_YET_RECRUITINGCentre Paul Strauss
Strasbourg, France
RECRUITINGEfficacy 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)
Time frame: up to 24 months
Percentage of recurrence of irradiated sites
Number of sites with recurrence over the number of irradiated sites
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: at 12 months
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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
Time frame: 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
Time frame: 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
Time frame: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value
SUV mean
Time frame: up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value
SUV peak
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12 months