Phase 2
N=48
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Metastatic Seminoma
Bottom Line
View on ClinicalTrials.gov: NCT02272816 ↗Enrolled (actual)
48
Serious AEs
25.0%
Results posted
Jan 2019
Primary outcome: Primary: 2 - Year Progression Free Survival — 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin AUC-10 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Barts & The London NHS Trust
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2 - Year Progression Free Survival |
46 | — |
| SECONDARY Metabolic Response Rate |
21; 26 | — |
| SECONDARY Overall Survival |
48; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02272816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.