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Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

NCT02272816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-01-25

Study results available
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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.

Conditions

  • Metastatic Seminoma

Interventions

DRUG

Carboplatin AUC-10

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.

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Jonathan Shamash, MD FRCP · Barts & The London NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-13
Primary Completion
2017-10-13
Completion
2017-10-13

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02272816 on ClinicalTrials.gov