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

ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Glioblastoma, World Health Organization (WHO) grade IV, histologically proven

Performance status 0, 1 or 2

Neurological status ≥ 2

Disqualifiers

Patient with contraindication to MRI or PET

Glioblastomatose

Pregnancy or breastfeeding

Patient that do not understand French

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simultaneous-integrated boost with IMRT

    Radiation

    Simultaneous-integrated boost guided by FDOPA-PET

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)Experimental treatment 1 intervention
Group B: Standard IMRTNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
up to 24 months

Secondary outcomes

1

Percentage of recurrence of irradiated sites

Number of sites with recurrence over the number of irradiated sites

Time frame
up to 24 months
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Paul Strauss

Lead sponsor

Centre Georges François Leclerc

Collaborator

Source ClinicalTrials.gov
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