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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Radiation: Simultaneous-integrated boost with IMRT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anne ANTHONY; Phone Number: 33 (0)388252413; Email: promotion-rc@institut-strauss.fr
• Study Contact Backup: Name: MANON VOEGELIN; Phone Number: 33 (0)3 68 33 95 23; Email: promotion-rc@institut-strauss.fr

Study Locations

• France
  • Strasbourg, France, 67033
    • Recruiting
    • Centre Paul Strauss
    • Sub-Investigator: Caroline BUND, MD, PhD
    • Principal Investigator: Clara LE FEVRE, MD
    • Contact: Clara LE FEVRE, MD; Email: promotion-rc@institut-strauss.fr
  • De
    • Nancy, De, France, 5400
      • Not yet recruiting
      • CHRU de Nancy
      • Contact: Luc TAILLANDIER, Pr; Email: l.taillandier@chru-nancy.fr
      • Principal Investigator: Luc TAILLANDIER, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Radiation: Simultaneous-integrated boost with IMRT; Simultaneous-integrated boost guided by FDOPA-PET
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of recurrence of irradiated sites	Number of sites with recurrence over the number of irradiated sites	up to 24 months
Characterization of recurrence sites: classified either as distant, marginal or in-field	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.	up to 24 months
Percentage of Recurrence free survival 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	At 6 months
Percentage of Recurrence free survival 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	at 12 months
Overall survival	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	From date of inclusion until the date of death from any cause, assessed up to 72 months
Tolerance of re-irradiation	Recording of toxicities (according to Common Terminology Criteria for Adverse Events v5 criteria) at each follow-up visit	up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV max value	Standardized Uptake Value (SUV) max	up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value	SUV mean	up to 24 months
Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value	SUV peak	up to 24 months
Quality of Life at 2 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)	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.	At 2 months
Quality of Life at 2 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)	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.	At 2 months
Quality of Life at 4 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)	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.	At 4 months
Quality of Life at 4 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)	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.	At 4 months
Quality of Life at 6 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)	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.	At 6 months
Quality of Life at 6 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)	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.	At 6 months
Quality of Life at 12 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)	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.	At 12 months
Quality of Life at 12 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)	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.	At 12 months

Collaborators and Investigators

• Sponsor: Centre Paul Strauss
• Collaborators: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Glioblastoma; Simultaneous Integrated Boost
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Therapeutics; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy, Intensity-Modulated
• Other Study ID Numbers: 2021-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No