Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272816
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
Barts & The London NHS Trust

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.

Condition or disease Intervention/treatment Phase
Metastatic Seminoma Drug: Carboplatin AUC-10 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 13, 2012
Actual Primary Completion Date : October 13, 2017
Actual Study Completion Date : October 13, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: Carboplatin AUC-10 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.




Primary Outcome Measures :
  1. 2 - Year Progression Free Survival [ Time Frame: 2 years ]
    Number of participants progression free 2 years after registration.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272816


Locations
Layout table for location information
United Kingdom
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Hillingdon Hospitals NHS Foundation Trust
London, United Kingdom, HA6 2RN
Sponsors and Collaborators
Barts & The London NHS Trust
University College London Hospitals
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Shamash, MD FRCP Barts & The London NHS Trust
  Study Documents (Full-Text)

Documents provided by Barts & The London NHS Trust:
Study Protocol  [PDF] August 31, 2017
Statistical Analysis Plan  [PDF] April 10, 2018


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT02272816    
Other Study ID Numbers: 007065
2009-009882-33 ( EudraCT Number )
First Posted: October 23, 2014    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Seminoma
Germinoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Carboplatin
Antineoplastic Agents