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

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Radiation

Study Type: Interventional

Study Phase: Phase 2

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

France

CHRU de Nancy

NOT_YET_RECRUITING

Nancy

Centre Paul Strauss

RECRUITING

Strasbourg

Contact Information

Primary

Anne ANTHONY

promotion-rc@institut-strauss.fr

(0)388252413

Backup

MANON VOEGELIN

promotion-rc@institut-strauss.fr

(0)3 68 33 95 23

Time Frame

Start Date: 2026-03-01

Estimated Completion Date: 2028-09-01

Participants

Target number of participants: 54

Treatments

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

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

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