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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Seminoma||Drug: Carboplatin AUC-10||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 2 - Year Progression Free Survival [ Time Frame: 2 years ]Number of participants progression free 2 years after registration.
- 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.
- Overall Survival [ Time Frame: 2 years ]Survival status at 2 years after registration.
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
|Barts Health NHS Trust|
|London, United Kingdom, EC1A 7BE|
|Hillingdon Hospitals NHS Foundation Trust|
|London, United Kingdom, HA6 2RN|
|Principal Investigator:||Jonathan Shamash, MD FRCP||Barts & The London NHS Trust|