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NCT Number: NCT05653635

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma 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

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About this study

Glioblastoma (GBM) is the most common cerebral tumor in adults. Despite well-conducted treatments including surgery, chemo-radiotherapy and chemotherapy according to the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) protocol, recurrences remain unavoidable within approximately 6 months and the overall survival rate of patients at 5 years is inferior to 10%.

In case of recurrence, a second surgery, radiotherapy under stereotaxic conditions, bevacizumab or other innovative techniques have been proposed. However, they are not yet considered as reference treatments, due to the absence of therapeutic trials definitively proving their efficacy.

Evaluation of GBM progression is based on MRI, corticosteroid intake and clinical status.However, positron emission tomography (PET) is an extremely relevant examination for differentiating between true progression and pseudo-progression. Indeed, an increase in the transfer of amino acids in 18 F-dihydroxyphenylalanine (FDOPA)-PET strongly suggests a recurrence. A local treatment can then be proposed by favoring surgery or, as an option, radiotherapy under stereotactic conditions. However, this treatment, even if it is well tolerated, has an efficacy which could be improved.

Often proposed option to improve efficacy of this radiation technic consists in increasing the dose of irradiation. This dose increase is often limited by the tolerance of nearby healthy tissue. It could however be possible with coupled techniques of intensity modulation and stereotaxy within the framework of an integrated boost (Simultaneous Integrated Boost - SIB). At each radiation session, the dose delivered to the tumor volume would be increased in the metabolic volume (BTV) detected by FDOPA-PET.

The objective of this study is to evaluate, in patients with recurrent glioblastoma, the efficacy of a dose increase using an SIB in a volume delineated with FDOPA-PET.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Simultaneous-integrated boost with IMRT

Radiation

Simultaneous-integrated boost guided by FDOPA-PET

Primary outcomes

  1. Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma

    Time frame: up to 24 months

    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)

Secondary outcomes

  1. Percentage of recurrence of irradiated sites

    Time frame: up to 24 months

    Number of sites with recurrence over the number of irradiated sites

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

    Time frame: up to 24 months

    Recurrence will be described according to their localisation by comparing images at recurrence with the images used for dosimetry. A recurrence will be defined as " distant" is it appears outside of 80% isodose, as "marginal" if it cuts 80% isodose and as "in-field" if it is completely located in 80% isodose. The 80% isodose is the reference isodose used for radiation therapy prescription.

  3. Percentage of Recurrence free survival at 6 months

    Time frame: At 6 months

    Interval between the date of inclusion in the trial until the date of recurrence of irradiated site (first recurrence, in case of multiple irradiation). Patients that are alive without recurrence at the end of the tiral will be censored

  4. Percentage of Recurrence free survival at 12 months

    Time frame: at 12 months

    Interval between the date of inclusion in the trial until the date of recurrence of irradiated site (first recurrence, in case of multiple irradiation). Patients that are alive without recurrence at the end of the tiral will be censored

  5. Overall survival

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

    Interval between the date of inclusion in the trial until the date of death whatever the cause. Patients that are alive without recurrence at the end of the tiral will be censored

  6. Tolerance of re-irradiation

    Time frame: up to 24 months

    Recording of toxicities (according to Common Terminology Criteria for Adverse Events v5 criteria) at each follow-up visit

  7. Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV max value

    Time frame: up to 24 months

    Standardized Uptake Value (SUV) max

  8. Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value

    Time frame: up to 24 months

    SUV mean

  9. Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value

    Time frame: up to 24 months

    SUV peak

  10. Quality of Life at 2 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At 2 months

    Quality of life will be measure with the 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. Quality of Life at 2 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 2 months

    Quality of life will be measured 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. Quality of Life at 4 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)

    Time frame: At 4 months

    Quality of life will be measure with the 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. Quality of Life at 4 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 4 months

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

    Time frame: At 6 months

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

    Time frame: At 6 months

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

    Time frame: At 12 months

    Quality of life will be measure with the 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.

  17. Quality of Life at 12 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)

    Time frame: At 12 months

    Quality of life will be measured 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.

Study contacts

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

Anne ANTHONY

CONTACT

[email protected]

(0)388252413 ext. 33

MANON VOEGELIN

CONTACT

[email protected]

(0)3 68 33 95 23 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Collaborators

  • Centre Georges François Leclerc

Registry information

Acronym: ReciDOPA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
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.

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