Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

Study Overview
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Brief Summary
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This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.

Official Title
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A Multi-Centre Phase II Study Using Carboplatin AUC-10 for Metastatic Seminoma With IGCCCG Good Prognosis Disease-Therapy Directed by Initial Metabolic Response on PET-CT

Conditions
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Metastatic Seminoma

Intervention / Treatment
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* Drug: Carboplatin AUC-10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable). Males aged ≥18 and ≤75 years. Able to give written informed consent prior to study entry. Patients must be sterile or agree to use adequate contraception during the period of therapy. Exclusion Criteria: Metastatic seminoma with any non-pulmonary visceral metastases. Raised Alpha-fetoprotein. Any previous chemotherapy or radiotherapy. Currently enrolled in any other investigational drug study. Other malignancy except basal cell.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin AUC-10<br> | Drug: Carboplatin AUC-10<br>* Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 - Year Progression Free Survival | Number of participants progression free 2 years after registration. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Response Rate | Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment. | 21 days | 
| Overall Survival | Survival status at 2 years after registration. | 2 years |