Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05653622

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHRU de Nancy, Nancy, De, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unfit patient without indication to the STUPP protocol :

Cohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients > 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available

  • Histologically proven glioblastoma
  • Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Overall Survival (OS)

    Time frame: At 24 months after inclusion

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

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: At 24 months after inclusion

    To assess the progression-free survival (PFS) of patients with glioblastoma treated with SIB with increased dose guided by FDOPA PET

  2. Sites of progression: distant, marginal or in-field progression

    Time frame: At the date of progression, assessed up to 24 months

    The progression will be defined by its location by comparing the progression imaging with that used for dosimetry. It will be considered "distant" if it develops beyond the 95% isodose, "marginal" if it cuts the 95% isodose and "in-field" if it is completely within the 95% isodose. The 95% isodose is the reference isodose for the prescription of hypofractionated radiotherapy.

  3. Assess the rate of acute complications of grade ≥ 3

    Time frame: At 6 months after the start of radiotherapy

    Acute toxicities are defined as toxicities by the Common Terminology Criteria for Adverse Events (CTCAE v5) occurring within 6 months of the start of radiotherapy.

  4. Characterize the PET parameters during progression

    Time frame: At the date of progression, assessed up to 24 months

    PET Parameters:

    • Standardized Uptake Value (SUV) max tumor, SUV max tumor/healthy tissue, SUV max T/striatum
    • SUV mean tumor, SUV mean tumor/healthy tissue, SUV mean T/striatum

  5. Evolution of the PET parameters

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

    PET Parameters:

    • Standardized Uptake Value (SUV) max tumor, SUV max tumor/healthy tissue, SUV max T/striatum
    • SUV mean tumor, SUV mean tumor/healthy tissue, SUV mean T/striatum

  6. Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At inclusion

    The quality of life will be measured at the inclusion with Quality of Life Questionnaire-C30 (Cancer 30items).

    All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  7. Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At inclusion

    The quality of life will be measured at the inclusion with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).

    All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  8. Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At 3 months after inclusion

    The quality of life will be measured at 3 months with Quality of Life Questionnaire-C30 (Cancer 30items).

    All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  9. Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 3 months after inclusion

    The quality of life will be measured at 3 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).

    All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  10. Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At 6 months after inclusion

    The quality of life will be measured at 6 months with Quality of Life Questionnaire-C30 (Cancer 30items).

    All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  11. Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 6 months after inclusion

    The quality of life will be measured at 6 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).

    All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  12. Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At 12 months after inclusion

    The quality of life will be measured at 12 months with Quality of Life Questionnaire-C30 (Cancer 30items).

    All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  13. Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 12 months after inclusion

    The quality of life will be measured at 12 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).

    All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  14. Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At 18 months after inclusion

    The quality of life will be measured at 18 months with Quality of Life Questionnaire-C30 (Cancer 30items).

    All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  15. Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 18 months after inclusion

    The quality of life will be measured at 18 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).

    All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  16. Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Overall survival

    Time frame: At 24 months after inclusion

    MGMT promoter methylation status (binary variable, determined by either Polymerase Chain reaction (PCR) or immunohistochemistry)

  17. Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Progression-Free Survival

    Time frame: At 24 months after inclusion

    MGMT promoter methylation status (binary variable, determined by either PCR or immunohistochemistry)

  18. Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and acute toxicities

    Time frame: At 24 months after inclusion

    MGMT promoter methylation status (binary variable, determined by either PCR or immunohistochemistry)

Study contacts

Contact information is provided by the study sponsor or research team.

Anne ANTHONY

CONTACT

[email protected]

+33(0)388252413

MANON VOEGELIN

CONTACT

[email protected]

+33(0)3 68 33 95 23

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Official study title

Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma

Acronym: SIB-DOPA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 16, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.