Ignite Creation Date:
2024-05-05 @ 11:50 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01424839
Status:
UNKNOWN
Last Update Posted:
2015-06-04
First Post:
2011-08-11
Brief Title:
Prospective Trial for the Diagnosis and Treatment of Intracranial Germ Cell Tumors
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
SIOP CNS GCT II Prospective Trial for the Diagnosis and Treatment of Children Adolescents and Young Adults With Intracranial Germ Cell Tumors
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIOPCNSGCTII
Brief Summary:
STUDY DESIGN
Prospective non-randomised multicentre study with patients stratified according to risk groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin Cisplatin Ifosfamide and Etoposide as approved by German competent authority
PRIMARY OBJECTIVES
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 irradiation - boosts
In metastatic disease to maintain current excellent EFS in metastatic germinoma with craniospinal irradiation Malignant non-germinoma
To improve EFS
by dose escalation of chemotherapy in patients identified as high risk at diagnosis age 6 years andor AFP serum CSF 1000 ngml
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
SECONDARY OBJECTIVES
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 fu-ture 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 collect and to store tumour material and CSF where possible for use in future biological studies
ENDPOINTS Criteria for evaluation
Main end point
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
Secondary end points
Overall survival defined as time to death from any cause measured from the date of diagnosis
Short and long term toxicity
Prospective non-randomised multicentre study with patients stratified according to risk groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin Cisplatin Ifosfamide and Etoposide as approved by German competent authority
PRIMARY OBJECTIVES
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 irradiation - boosts
In metastatic disease to maintain current excellent EFS in metastatic germinoma with craniospinal irradiation Malignant non-germinoma
To improve EFS
by dose escalation of chemotherapy in patients identified as high risk at diagnosis age 6 years andor AFP serum CSF 1000 ngml
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
SECONDARY OBJECTIVES
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 fu-ture 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 collect and to store tumour material and CSF where possible for use in future biological studies
ENDPOINTS Criteria for evaluation
Main end point
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
Secondary end points
Overall survival defined as time to death from any cause measured from the date of diagnosis
Short and long term toxicity
Detailed Description:
PATIENT POPULATION Age of patients no lower or upper age limit Estimated number 400 malignant germ cell tumours
Diagnosis and main criteria for inclusionexclusion
Intracranial Germ Cell tumours of any histology and intracranial site and dissemination
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 trans-fer
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 registration
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 andor 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 eg trials on antiemetics antimycotics antibiotics strategies for psychosocial support etc
Pregnancy and lactation
Any treatment not given according to protocol prior to registration
TREATMENT
GERMINOMA
Chemotherapy
Non-metastatic fully staged germinoma teratoma Two courses 1 and 3 of Etoposide and Carboplatin alternating with two courses 2 and 4 of Etoposide and Ifosfamide Note Bifocal germinoma pinealsuprasellar are treated as non-metastatic germinoma if stag-ing shows no additional dissemination
Metastatic or incompletely staged germinomas teratoma Do not receive chemotherapy in this protocol
Radiotherapy
Non-metastatic pure germinoma in PRSD After Chemotherapy 24 Gy 15 fractions to whole ventricles with a 16 Gy 10 fraction boost to tumour bed total tumour dose 40 Gy
Non-metastatic germinoma in CR After Chemotherapy 24 Gy 15 fractions to whole ventricles
Metastatic or incompletely staged pure germinoma 24 Gy 15 fractions to craniospinal axis with a 16 Gy 10 fraction boost to tumour bed and any intracranial metastases and spinal deposits total tumour dose 40 Gy
Non-metastatic germinoma plus teratoma incompletely resected After Chemotherapy 24 Gy 15 fractions to whole ventricles 304 Gy 19 fraction boost to tumour bed total tumour dose 544 Gy
Metastatic germinoma plus teratoma incompletely resected 24 Gy 15 fractions to craniospinal axis 304 Gy 19 fraction boost to tumour bed and 16 Gy 10 frac-tion boost to metastases total tumour dose 544 Gy
NON-GERMINOMA TERATOMA
Chemotherapy
Standard risk non-germinomatous malignant GCT Four courses of Etoposide Cisplatin and Ifosfamide standard treatment
High risk non-germinomatous malignant GCT Two courses of standard Etoposide Cisplatin and Ifosfamide followed by two dose intensified courses of Etoposide Cisplatin and Ifosfamide with stem cell support
Resection of residual tumour after 3 courses chemotherapy if indicated followed by 4th course If vi-able cells are found in the resected tumour specimen patient is transferred to the high risk arm
Radiotherapy for standard and high risk non-germinomatous malignant GCT
Patients with localised disease at diagnosis After Chemotherapy 54 Gy focal radiotherapy in 30 fractions
Patients with metastatic disease at diagnosis After Chemotherapy 30 Gy 20 fractions to craniospinal axis with 24 Gy 15 fraction boosts to tumour site and any intracranial metastases total tumour dose 54 Gy and 208 Gy 13 fraction boosts to spinal deposits total dose 508 Gy
SPECIAL ASPECTS
Central response evaluation on a national basis
Germinoma In all patients with localised germinoma a central national radiological review is mandatory for response evaluation to chemotherapy and decision if only ventricular irradiation or an additional tu-mour boost has to be performed
Non-Germinoma After three courses of chemotherapy to evaluate response to treatment and to deter-mine necessity of surgery in case of residual before radiotherapy
Diagnosis and main criteria for inclusionexclusion
Intracranial Germ Cell tumours of any histology and intracranial site and dissemination
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 trans-fer
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 registration
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 andor 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 eg trials on antiemetics antimycotics antibiotics strategies for psychosocial support etc
Pregnancy and lactation
Any treatment not given according to protocol prior to registration
TREATMENT
GERMINOMA
Chemotherapy
Non-metastatic fully staged germinoma teratoma Two courses 1 and 3 of Etoposide and Carboplatin alternating with two courses 2 and 4 of Etoposide and Ifosfamide Note Bifocal germinoma pinealsuprasellar are treated as non-metastatic germinoma if stag-ing shows no additional dissemination
Metastatic or incompletely staged germinomas teratoma Do not receive chemotherapy in this protocol
Radiotherapy
Non-metastatic pure germinoma in PRSD After Chemotherapy 24 Gy 15 fractions to whole ventricles with a 16 Gy 10 fraction boost to tumour bed total tumour dose 40 Gy
Non-metastatic germinoma in CR After Chemotherapy 24 Gy 15 fractions to whole ventricles
Metastatic or incompletely staged pure germinoma 24 Gy 15 fractions to craniospinal axis with a 16 Gy 10 fraction boost to tumour bed and any intracranial metastases and spinal deposits total tumour dose 40 Gy
Non-metastatic germinoma plus teratoma incompletely resected After Chemotherapy 24 Gy 15 fractions to whole ventricles 304 Gy 19 fraction boost to tumour bed total tumour dose 544 Gy
Metastatic germinoma plus teratoma incompletely resected 24 Gy 15 fractions to craniospinal axis 304 Gy 19 fraction boost to tumour bed and 16 Gy 10 frac-tion boost to metastases total tumour dose 544 Gy
NON-GERMINOMA TERATOMA
Chemotherapy
Standard risk non-germinomatous malignant GCT Four courses of Etoposide Cisplatin and Ifosfamide standard treatment
High risk non-germinomatous malignant GCT Two courses of standard Etoposide Cisplatin and Ifosfamide followed by two dose intensified courses of Etoposide Cisplatin and Ifosfamide with stem cell support
Resection of residual tumour after 3 courses chemotherapy if indicated followed by 4th course If vi-able cells are found in the resected tumour specimen patient is transferred to the high risk arm
Radiotherapy for standard and high risk non-germinomatous malignant GCT
Patients with localised disease at diagnosis After Chemotherapy 54 Gy focal radiotherapy in 30 fractions
Patients with metastatic disease at diagnosis After Chemotherapy 30 Gy 20 fractions to craniospinal axis with 24 Gy 15 fraction boosts to tumour site and any intracranial metastases total tumour dose 54 Gy and 208 Gy 13 fraction boosts to spinal deposits total dose 508 Gy
SPECIAL ASPECTS
Central response evaluation on a national basis
Germinoma In all patients with localised germinoma a central national radiological review is mandatory for response evaluation to chemotherapy and decision if only ventricular irradiation or an additional tu-mour boost has to be performed
Non-Germinoma After three courses of chemotherapy to evaluate response to treatment and to deter-mine necessity of surgery in case of residual before radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-018072-33 | EUDRACT_NUMBER | None | None |