Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma

NCT05653622 | Recruiting Phase 2

• 1 other identifier: 2021-010
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months. Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ. For some, the radiation dose is not optimal. Moreover, recurrences develop mainly in the initial tumor site. These two reasons justify increasing the dose. To limit the movements of these fragile patients, the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost (SIB) which increases the dose in targeted volumes while the rest of the volume receives a minimum dose. A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI. FDOPA PET detects certain more aggressive tumor areas, areas likely to recur. Integrating them into the SIB seems appropriate. A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS. This study differed from the one the investigators propose, because a dose and conventional fractionation, identical to that of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (NCIC/EORTC) protocol were delivered, the gliomas were unmethylated MGMT, less likely to respond. Studies with SIB and hypofractionation are often retrospective and for others, hypofractionation was debatable and the dose increase was not based on PET capture but on MRI. However, a prospective phase II study, with SIB and hypofractionation, not integrating FDopa PET has demonstrated the relevance of SIB. In this project, the investigators propose to use the integrated boost technique (SIB) guided by PET FDOPA to increase the radiation dose in GBM, in patients either fragile and partially operated, or only biopsied and for whom the prognosis is the most pejorative.

Conditions

Glioblastoma Multiforme, Adult

Keywords

glioblastoma; intensity modulated radiation therapy; 18F-DOPA-PET imaging

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Evaluate the overall survival (OS) of patients with glioblastoma treated with integrated boost (SIB) with increased dose guided by FDOPA PET

  At 24 months after inclusion

Secondary Outcomes (18)

• Progression-Free Survival (PFS)

  At 24 months after inclusion

• Sites of progression: distant, marginal or in-field progression

  At the date of progression, assessed up to 24 months

• Assess the rate of acute complications of grade ≥ 3

  At 6 months after the start of radiotherapy

• Characterize the PET parameters during progression

  At the date of progression, assessed up to 24 months

• Evolution of the PET parameters

  Change between baseline and the date of progression, assessed up to 24 months

Study Arms (1)

SIB-DOPA

EXPERIMENTAL

Procedure: Integrated boost technique (SIB) guided by PET FDOPA

Interventions

Integrated boost technique (SIB) guided by PET FDOPA PROCEDURE

intensity-modulated irradiation scheme with integrated boost technique (SIB) guided by PET FDOPA during the chemo-radiotherapy

SIB-DOPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unfit patient without indication to the STUPP protocol :
• Histologically proven glioblastoma
• Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)

You may not qualify if:

• Patients with an indication for irradiation according to the STUPP protocol (fit patient)
• Patient with a contraindication to MRI or PET
• Limit of the provisional target volume or Planning target volume (PTV), second PTV \< 2 cm from the chiasm and the optic nerves
• Absence of uptake of FDopa

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (3)

CHRU de Nancy

Nancy, De, 5400, France

RECRUITING

Centre Paul Strauss

Strasbourg, France

RECRUITING

ICL

Vandœuvre-lès-Nancy, France

RECRUITING

Related Publications (3)

• Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, Fay M, Nishikawa R, Cairncross JG, Roa W, Osoba D, Rossiter JP, Sahgal A, Hirte H, Laigle-Donadey F, Franceschi E, Chinot O, Golfinopoulos V, Fariselli L, Wick A, Feuvret L, Back M, Tills M, Winch C, Baumert BG, Wick W, Ding K, Mason WP; Trial Investigators. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. N Engl J Med. 2017 Mar 16;376(11):1027-1037. doi: 10.1056/NEJMoa1611977.

  PMID: 28296618 BACKGROUND

• Truc G, Bernier V, Mirjolet C, Dalban C, Mazoyer F, Bonnetain F, Blanchard N, Lagneau E, Maingon P, Noel G. A phase I dose escalation study using simultaneous integrated-boost IMRT with temozolomide in patients with unifocal glioblastoma. Cancer Radiother. 2016 May;20(3):193-8. doi: 10.1016/j.canrad.2015.12.005. Epub 2016 Apr 23.

  PMID: 27117900 BACKGROUND

• Somme F, Bender L, Namer IJ, Noel G, Bund C. Usefulness of 18F-FDOPA PET for the management of primary brain tumors: a systematic review of the literature. Cancer Imaging. 2020 Oct 6;20(1):70. doi: 10.1186/s40644-020-00348-5.

  PMID: 33023662 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Caroline BUND

  Centre Paul Strauss

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne ANTHONY

CONTACT

+33(0)388252413; promotion-rc@institut-strauss.fr

MANON VOEGELIN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 16, 2022
• Study Start: June 23, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (3)