NCT05653635

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
29mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

November 28, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
3.2 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

November 28, 2022

Last Update Submit

February 2, 2026

Conditions

Glioblastoma

Keywords

GlioblastomaSimultaneous Integrated Boost

Outcome Measures

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)

    up to 24 months

Secondary Outcomes (17)

  • Percentage of recurrence of irradiated sites

    up to 24 months

  • Characterization of recurrence sites: classified either as distant, marginal or in-field

    up to 24 months

  • Percentage of Recurrence free survival at 6 months

    At 6 months

  • Percentage of Recurrence free survival at 12 months

    at 12 months

  • Overall survival

    From date of inclusion until the date of death from any cause, assessed up to 72 months

  • +12 more secondary outcomes

Study Arms (2)

Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)

EXPERIMENTAL

* 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

Radiation: Simultaneous-integrated boost with IMRT

Standard IMRT

NO INTERVENTION

* 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

Simultaneous-integrated boost with IMRTRADIATION

Simultaneous-integrated boost guided by FDOPA-PET

Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Nancy

Nancy, De, 5400, France

NOT YET RECRUITING

Centre Paul Strauss

Strasbourg, 67033, France

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Central Study Contacts

Anne ANTHONY

CONTACT

(0)388252413promotion-rc@institut-strauss.fr

MANON VOEGELIN

CONTACT

(0)3 68 33 95 23promotion-rc@institut-strauss.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 16, 2022

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

FR(2)