E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intracranial germ cell tumours of any histology and intracranial site and dissemination |
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E.1.1.1 | Medical condition in easily understood language |
Germ cell tumours of the brain |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065853 |
E.1.2 | Term | Nongerminomatous germ cell tumor of the CNS |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018207 |
E.1.2 | Term | Germinoma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Germinoma: -To maintain current high event-free survival (EFS) rates using a risk adapted approach -In localised germinoma: to omit whole brain and spinal irradiation by using combined treatment with standard chemotherapy and ventricular irradiation (+/- boosts) -In bifocal tumours (pineal + suprasellar): to treat as non-metastatic disease and to omit whole brain and spinal irradiation by using combined treatment with standard chemotherapy and ventricular irra-diation (+/- boosts) -In metastatic disease: to maintain current excellent EFS in metastatic germinoma with craniospinal irradiation Malignant non-germinoma -To improve EFS in high risk patients by intensifying treatment -by dose escalation of chemotherapy in patients identified as high risk at diagnosis -by standardising the surgical approach for residual disease after treatment Teratoma -To register patients and collect data regarding diagnostics, treatment and outcome in order to develop future treatment strategies |
Germinom:Bibehålla den goda EFS genom att använda ett riskanpassat tillvägagångssätt - Lokaliserat germinom:ej använda total kraniospinal strålterapi utan istället kombinerad behandling av standardcytostatika och ventrikulär strålterapi (+/- tumörboost) - Bifokala tumörer:behandla som icke-metastatisk sjukdom och ej använda total kraniospinal strålterapi utan istället använda kombinerad behandling av standardcytostatika och ventrikulär strålterapi (+/- tumörboost) - Metastaser:fortsätta underhålla det utmärkta EFS m kraniospinal strålterapi Maligna non-germinom:Förbättra EFS hos högriskpatienter m intensifierad behandling, detta görs genom: - doseskalering av standardcytostatikabehandlingen hos de som identifieras som högriskpatienter vid diagnos - standardisering av det kirurgiska tillvägagångssättet vid kvarvarande sjukdom efter behandling Teratom: registrera patienter och samla data angående diagnosticering, behandling och utfall för att kunna utveckla framtida behandlingsstrategier |
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E.2.2 | Secondary objectives of the trial |
Germinoma - To minimise long term effects of irradiation by sparing spinal and whole brain radiotherapy in non-metastatic disease Malignant non-germinoma - In standard risk to maintain EFS with chemotherapy and local irradiation Teratoma - To evaluate the influence of surgery and treatment on outcome to assist in the development of a future treatment strategy For all histological subtypes - To improve accuracy of diagnosis and staging in all registered patients - To standardise neurosurgical intervention - For all patients requiring biopsy or resection according to protocol guidelines, to store tumour material, and CSF where possible, for use in future biological studies |
Germinom: - minimera långtidseffekten av strålning genom att inte använda total kraniospinal strålterapi vid icke metastatisk sjukdom
Maligna non-germinom: - vid standardrisk att underhålla EFS med standard cytostatika och lokal strålterapi
Teratom: - att utvärdera utfallet av kirurgi och behandling för att i framtiden kunna ta fram en behandlingsstrategi
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Main residence in one of the participating countries • Primary diagnosis of an intracranial germ cell tumour • Written consent for trial participation, treatment according to the protocol and consent for data transfer
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- huvudsakligt uppehåll i ett av de i studien deltagande länderna - intrakraniell germinalcellstumör som primär diagnos - patienten och/eller vårdnadshavarna har lämnat sitt skriftliga samtycke
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E.4 | Principal exclusion criteria |
• Tumour entity other than primary intracranial germ cell tumour or CNS GCT as second malignancy • Primary diagnosis pre-dating the opening of SIOP CNS GCT II in the participating country of registra-tion • Medical, psychiatric or social conditions incompatible with trial treatment or treatment according to protocol is not intended • Participation within a different trial for treatment of germ cell tumours and/or concurrent treatment within any other clinical trial. The only exceptions to this are trials with different endpoints, involving aspects of supportive treatment which can run parallel to SIOP CNS GCT II without influencing the outcome of this trial e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support etc. • Pregnancy and lactation • Any treatment not given according to protocol prior to registration
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- primär diagnos innan SIOP CNS GCT II startat - patienter med CNS GCT som sekundär malignitet - patienter som man inte tänkt behandla enligt studieprotokollet - patienter med ett medicinskt, psykiatriskt eller socialt tillstånd som innebär att de inte kan följa protkollbehandlingen - deltagande i en annan studie som behandlar germinalcellstumörer och/eller samtidig behandling i någon annan klinisk studie. De enda undantagen är studier med avvikande endpoints, som involverar aspekter av stödjande behandling vilka kan gå parallellt med SIOP CNS GCT II utan att påverka utfallet av studien t ex studier på antiemetika, antimykotika, antibiotika, strategier för psykosocial support etc - graviditet och amning - behandling som inte givits enligt protokollet innan registrering
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E.5 End points |
E.5.1 | Primary end point(s) |
Event-free survival, defined as minimum time from the date of diagnosis to: • Death from any cause • Relapse • Progressive disease on therapy • Or second malignancy
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 years following the last patient recruited |
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E.5.2 | Secondary end point(s) |
• Overall survival, defined as time to death from any cause, measured from the date of diagnosis • Short and long term toxicity.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 years following the last patient recruited |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of life, neuropsychological basis diagnosis system |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 120 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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2 years following the last patient recruited |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |