Dettagli per singolo studio

DEC-NET Serial number GB478

Published online	19/09/2005 16.16.00
Last updated	19/09/2005 17.08.34


This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	04/2004 29
Major Disease (ICD9 class)	MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NER
Experimental drug
CCNU Treatment regimen (dosage and duration) 75 mg/m2 per course (on day 1) oral - 8 courses -each course every 6 weeks,
Cisplatin Treatment regimen (dosage and duration) 70mg/m2 every 6 weeks for 8 courses post-radiotherapy chemotherapy (intravenous) 48 weeks
Vincristine Treatment regimen (dosage and duration) 1.5mg/m2 weekly during radiotherapy (intravenous) 7 weeks during radiotherapy, 1.5mg/m2 weekly x3 during post-radiotherapy - 8 courses - each course every 6 weeks.
Paraplatin Treatment regimen (dosage and duration) 400 mg/m2 per course (on day 1) intravenous - substituted for cisplatin in case of ototoxicity or renal toxicity
Gender	Both
Age (range)	3 - 18 years inclusive
Eligibility criteria
Inclusion criteria
Histolgically proven non-pineal supratentorial primitive neuroectodermal tumours Localised or metastic disease (defined as): - unequivocal evidence on pre-operative or postoperative MR scan of supretentorial metastases - and/or spinal metatases - and/or tumour cells seen on cytospin analysis of lumbar CSF (stage M1) performed between 15 days and 21 days after surgery Written and verbal informed consent by parent/ child
Exclusion criteria
Supratentorial atypical teratoid/rhabdoid tumours and medulloepitheliomas The presence of active uncontrolled infection Previous malignant disease Previous chemotherapy or radiotherapy Unable to comply with protocol Pregnant or lactating
Trial design/methodology
Phase	2
Kind of study	Pharmacokinetics
Design
Purpose of study
To establish the toxity of hyperfractionated accelerated radiotherapy (hart) in patients with supratentorial non-pineal primitive neuroectodermal tumours (StPNETS).
Primary outcomes
To establish the toxity of hyperfractionated accelerated radiotherapy (hart) in patients with supratentorial non-pineal primitive neuroectodermal tumours (StPNETS).
Secondary outcomes
to establish relapse free and overall survival and the toxity of chemotherapy in association with HART;
Summary of study design, objectives, and ongoing research findings
This is a novel radiotherapy regimen which is hoped will improve the outcome for this group of children who have a poor prognosis. The aim of the study are to establish the toxicity of hyperfractionated accelerated radiotherapy (HART) in patients with metastatic medulloblastoma. To establish the toxicity of chemotherapy in accociation with HART in patients with metastatic medulloblastoma. The chemotherapy used will be the international "standard" regimen, of cisplatin, CCNU and vincristine. There will be careful prospective monitoring of toxicity of HART alone together with chemotherapy. Methodology description: The clinical trial will be carried out in two phases. The first phase will include up to 7 patients, and will examine the toxicity of HART alone. Toxicity will be monitored during HART radiotherapy and for eight weeks following the end of radiotherapy. It is assumed that all acute toxicity ralated to radiotherapy (including somnolence and myelosuppression) will have resloved by this time. Eight weeks following the end of radiotherapy, patients will commence chemotherapy with CCNU, cisplatin and vincristine. Sample group description: When 7 patients have completed the first phase of the study, and providing stopping rules have not been reached, the second phase of the study will begin. Phase 2 will recruit up to a further 22 patients. This phase of the study is designed to examine the toxicity of HART delivered with 8 doses of vincristine given weekly during radiotherapy, and to look for any unexpected toxicity of the first cycle of maintainance chemotherapy such as radiation recall, excessively prolonged myelosuppression and neurotoxicity. For phase 2 of the study, the timing of the start of the first cycle of maintainance chemotherapy is provisionally set for six weeks following the end of radiotherapy, providing blood count recovery has occurred. A total of 29 patients are to be recruited. Outcome measure description: Clinical and experimental evidence exists to suggest that HFRT may improve the therapeutic ratio and also tumour control without an increase In long-term side effects. Hyperfractionated accelerated radiotherapy (HART) introduces the concept of hyperfractionation and acceleration (ie. Shortening overall duration of radioherapy). This element of acceleration may reduce the potential for "repopulation" ie. Growth of tumour cells during radiotherapy. It is hoped that this will lead to an improved outcome for children with metastatic.