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

Glioblastoma Clinical Trial

— ReciDOPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05653635
• Other study ID #: 2021-011
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: December 2022
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Manon VOEGELIN
• Phone: (0)36833952
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Radiation:
• Simultaneous-integrated boost with IMRT
Simultaneous-integrated boost guided by FDOPA-PET

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	Centre Georges François Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of recurrence of irradiated sites	Number of sites with recurrence over the number of irradiated sites	up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value	SUV mean	up to 24 months
Secondary	Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value	SUV peak	up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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