Clinical trial NCT02272816: Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Seminoma
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2014-10-23
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: 2 - Year Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Metabolic Response Rate
timeFrame: 21 days
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Hillingdon Hospitals NHS Foundation Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Jonathan Shamash, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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