Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma (Car-PET)

Barts & The London NHS Trust

Status and phase: Completed; Phase 2

Conditions: Metastatic Seminoma

Treatments: Drug: Carboplatin AUC-10

Study type: Interventional

Funder types: Other

Identifiers

NCT02272816

2009-009882-33 (EudraCT Number)

007065

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Carboplatin AUC-10

Experimental group

Treatment:

Drug: Carboplatin AUC-10