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

Centre Paul Strauss

Status and phase: Enrolling; Phase 2

Conditions: Glioblastoma

Treatments: Radiation: Simultaneous-integrated boost with IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT05653635

2021-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)

Experimental group

Description:

* 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

Treatment:

Radiation: Simultaneous-integrated boost with IMRT

Standard IMRT

No Intervention group

Description:

* 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