Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05653635
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut de cancérologie Strasbourg Europe
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Simultaneous-integrated boost with Intensity-modulated radiation therapy (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

No Intervention: Standard IMRT

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

Interventions

Radiation: - Simultaneous-integrated boost with IMRT

Simultaneous-integrated boost guided by FDOPA-PET

Contact a Trial Team

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International Sites

Strasbourg, France

Status

Address

Institut de cancérologie Strasbourg Europe

Strasbourg, , 67033

Site Contact

Manon VOEGELIN

promotion-rc@icans.eu

(0)36833952

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