Intracranial germinoma Cancer
Conditions
Interventions
In this study the participants diagnosed with localised intracranial germinoma will receive either carboplatin or vinblastine monotherapy (Stratum 1). Carboplatin monotherapy: Intravenous (IV) carbopl
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients: 1. Any age 2. Diagnosis 2.1. Primary diagnosis of histologically proven intracranial pure germinoma (i.e., with no evidence of non-germinomatous components – teratoma, yolk sac tumour/endodermal sinus tumour, embryonal carcinoma, and/or choriocarcinoma), except those with primary basal ganglia tumours 2.2. Bifocal disease with typical clinical/radiological characteristics (i.e., age =8–10 years, presence of diabetes insipidus, and loss of pituitary bright spot on imaging), without histologically proven intracranial pure germinoma after confirmation of eligibility by clinical coordinators 3. Serum and cerebrospinal fluid (CSF) alpha-fetoprotein (AFP) < 25 ng/ml (i.e. <21 ku/l; conversion is 1 ng/ml = 0.83 ku/l) 4. Serum and CSF human chorionic gonadotrophin (HCG) < 50 IU/L 5. Adequate liver function documented by: 5.1. Bilirubin = 1.5 x ULN unless known Gilbert’s syndrome or other similar liver syndrome 5.2. Serum ALT and/or AST liver enzyme(s) = 5 x ULN 6. Patients of reproductive potential must agree to use highly effective contraception during treatment and for six months afterwards 7. Documented negative pregnancy test for females of reproductive potential 8. Patient willing and able to comply with scheduled visits, treatment plan, and other study procedures 9. Written informed consent for the trial Stratum 1 specific inclusion criteria: 1. Localised disease (NOTE: bifocal disease alone is allowed and considered localized) 2. Negative CSF cytology 3. Measurable disease by Magnetic resonance imaging (MRI) Stratum 2 specific inclusion criteria: 1. Metastatic disease on MRI imaging AND/OR CSF cytology positive for tumour cells 2. Measurable disease by MRI at primary and/or metastatic site(s) 3. Planned start dates of radiotherapy = two weeks from intracranial germinoma diagnosis
Exclusion criteria
Exclusion criteria: All patients: 1. Pregnant or lactating patients 2. Primary basal ganglia tumours (difficult to define tumour volume and response; NOTE: primary measurable suprasellar tumour with contiguous extension into basal ganglia may be included) 3. Contraindication to MRI/receiving contrast 4. Known hypersensitivity to any of the MonoGerm treatments or excipients 5. Live attenuated vaccine given within 30 days 6. Patients for whom non-compliance with treatment, trial procedures, or protocol follow up schedule is expected and all available resources to facilitate inclusion have been exhausted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response (CR) is defined as the occurrence of a radiological CR by 12 weeks from MRI scans using the 2022 international neuroradiology consensus criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CRi is defined as the occurrence of a radiological CR, in the same way as the primary outcome measure, but using the historical European SIOPE criteria. 2. CRii is defined as the occurrence of a radiological CR, in the same way as the primary outcome measure, but using the historical North American (COG) criteria. 3. Objective Response (OR) in Stratum 1 is defined as the occurrence of a radiological CR or partial response (PR), from MRI scans using the 2022 international neuroradiology consensus criteria. 4. Overall Response is defined as the occurrence of a CR, PR, stable disease (SD), progressive disease (PD), or non-evaluable (NE) from MRI scans using the 2022 international neuroradiology consensus criteria. 5. Progression-Free Survival Time (PFS) is defined as the time from date of treatment starting to date of the first failure event, where a failure event is defined as a progression, recurrence, or disease or treatment-related death. Patients without an event at the point of analysis will be censored at the date they were last known to be alive and progression-free. 6. Overall Survival Time (OS) is defined as the time from date of treatment starting to date of disease or treatment-related death. Patients without a death date at the point of analysis will be censored at the date they were last known to be alive. 7. Adverse Reactions (ARs) are the occurrence of relevant adverse events (AEs) that are categorised as possibly, probably or definitely related to treatment using a risk-based approach (see Section 9) defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. All serious and non-serious reactions will be reported. 8. Quality-of-Life (QoL) is measured using age-appropriate children, adolescent and young adult PedsQL v4.0 Generic Core Scales and v1.0 Brain Tumour modules. and will be assessed at baseline, 3, 6, 9, and 12 weeks. 9. Neuroradiological Response, for the secondary objective, is d | — |
Countries
England, Scotland, United Kingdom
Contacts
Public Contact. Study Team
Outcome results
None listed