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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-005295-27-GB |
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Date of registration:
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16/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A NOVEL HYBRID PROTOCOL FOR RELAPSED GERM CELL TUMOURS
WITH POOR PROGNOSIS - GAMIO
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Scientific title:
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A NOVEL HYBRID PROTOCOL FOR RELAPSED GERM CELL TUMOURS
WITH POOR PROGNOSIS - GAMIO |
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Date of first enrolment:
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14/05/2009 |
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Target sample size:
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47 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005295-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
INCLUSION
1. Germ Cell Tumour (GCT)
2. Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on CT)
3. Neutrophil count > 1.0 x109/l
4. Platelets > 70 x109/l
5. Haemoglobin > 100g/l (may be transfused)
6. Calculated Creatinine clearance > 60mls/min or EDTA clearance of > 40ml/min
7. Age 16-65 years (Patient under 35 must have a raised LDH at relapse)
8. ECOG Performance status 0-3
9. FDG-PET CT scans prior to chemotherapy (within 14 days of study entry).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
EXCLUSION
1 Other malignancy except basal cell carcinoma
2 Significant co-morbidity likely to make delivery of this treatment unsafe
3 Currently enrolled in any other investigational drug study
4 Unable or unwilling to give written informed consent
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsed Germ Cell Tumour with poor prognosis
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Intervention(s)
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Product Name: Methotrexate
Pharmaceutical Form: Solution for injection
Trade Name: Neulasta
Product Name: pegfilgrastim
Pharmaceutical Form: Solution for injection
Product Name: Oxaliplatin
Pharmaceutical Form: Solution for infusion
Product Name: Irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
Product Name: Actinomycin D
Pharmaceutical Form: Intravenous infusion
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Primary Outcome(s)
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Secondary Objective:
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Primary end point(s): PRIMARY ENDPOINTS
• FDG PET-CT Scan metabolic response
• Toxicity
• Objective response rate
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Main Objective: 1. To establish the response rates to GAMIO
2. To establish the safety and efficacy of substitution of oxaliplatin and irinotecan for cisplatin and etoposide
3. To establish the toxicity of GAMIO
4. To establish progression free survival (PFS)
5. To ascertain whether a repeat FDG PET-CT scan at 14 days (after 1 cycle of therapy but prior to cycle 2) may predict long-term, progression-free survival following GAMIO.
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Secondary ID(s)
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TE 2008 01
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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