Skip to main content
OpenTrials
Completed

NCT Number: NCT02272816

Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Seminoma Germinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Seminoma

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Barts Health NHS Trust, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carboplatin AUC-10

Drug

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.

Primary outcomes

  1. 2 - Year Progression Free Survival

    Time frame: 2 years

    Number of participants progression free 2 years after registration.

Secondary outcomes

  1. Metabolic Response Rate

    Time frame: 21 days

    Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.

  2. Overall Survival

    Time frame: 2 years

    Survival status at 2 years after registration.

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • University College London Hospitals

Registry information

Official study 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

Acronym: Car-PET

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2014
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.