Metastatic Seminoma Clinical Trial
— Car-PETOfficial title:
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
| Verified date | August 2018 |
| Source | Barts & The London NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | October 13, 2017 |
| Est. primary completion date | October 13, 2017 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis. 2. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min. 3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3. 4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable). 5. Males aged =18 and =75 years. 6. Able to give written informed consent prior to study entry. 7. Patients must be sterile or agree to use adequate contraception during the period of therapy. Exclusion Criteria: 1. Metastatic seminoma with any non-pulmonary visceral metastases. 2. Raised Alpha-fetoprotein. 3. Any previous chemotherapy or radiotherapy. 4. Currently enrolled in any other investigational drug study. 5. Other malignancy except basal cell. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Barts Health NHS Trust | London | |
| United Kingdom | Hillingdon Hospitals NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Barts & The London NHS Trust | University College London Hospitals NHS Foundation Trust |
United Kingdom,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 2 - Year Progression Free Survival | Number of participants progression free 2 years after registration. | 2 years | |
| Secondary | 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 | |
| Secondary | Overall Survival | Survival status at 2 years after registration. | 2 years |