Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.

ConditionMeningioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorCentro di Riferimento Oncologico - Aviano

About this trial

High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 16 years;

Ability to express appropriate informed consent to treatment;

Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;

In case of recurrence, confirmation can be either histological or radiological;

Disqualifiers

Refusal to radiation treatment (i.e., absence of signed informed consent);

Other concomitant oncologic therapies

Current pregnancy;

Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose escalation of radiation therapy, based on somatostatin receptor PET imaging

    Radiation

    Radiation treatment with higher doses than the standard and defined using PET imaging

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: Dose escalation of radiation therapy, based on somatostatin receptor PET imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of brain radionecrosis

Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).

Time frame
up to 13 years
2

Assess progression free survival (progression free survival = PFS) at 3 years

Percentage of patients alive and free of disease progression at 3 years after the start of radiotherapy (PFS rate). Progression will be defined as increase in size of treated lesions or appearance of new lesions (according to RANO meningioma criteria)

Time frame
up to 13 years

Secondary outcomes

1

Overall survival (Overall survival = OS)

Overall survival (OS) will be defined as time between enrollment and death

Time frame
up to 13 years
2

Incidence of other toxicities

Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0

Time frame
up to 13 years
3

Concordance between GTV-RM and GTV-PET

Concordance will be measured according to Dice Similarity coefficient

Time frame
up to 13 years

Other outcomes

Sponsors and contacts

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