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

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.

Interventions

• Simultaneous-integrated boost with IMRT · RADIATION

  Simultaneous-integrated boost guided by FDOPA-PET

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (2)

• CHRU de Nancy, Nancy, De, France · NOT_YET_RECRUITING
• Centre Paul Strauss, Strasbourg, France · RECRUITING