Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy (Gemtrans)
The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy|
- Does response at Cystoscopy correlate with results of sample analysis [ Time Frame: 3 months following the end of GemX chemoradiation ] [ Designated as safety issue: No ]To test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hrs post-infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy. Gemcitabine will be measured in plasma by HPLC-MS using a published validated method. We have developed an assay for intracellular gemcitabine triphosphate which should determine levels in PBMCs from 10 - 15 ml blood. Response at Cystoscopy is measured as either complete response, superficial disease or muscle-invasive disease.
- cause-specific and overall survival rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- acute and late toxicities as assessed by RTOG and LENT SOM scales [ Time Frame: 3 years ] [ Designated as safety issue: No ]Toxicity is measured using LENT-SOMA (patient-reported) and CTCAE v4.0 (clinical assessment) during treatment and at follow up.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
This is a single arm study. Patients will be seen on day 1, 8, 15 and 22 and will have the following samples collected:
Other: sample collection
Blood samples will be collected on days 1, 8, 15 and 22. They will be taken 30 minutes and 2 hours post Gemcitabine infusion.Other: sample collection
Urine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post GemcitabineOther: Sample Collection
Quality of Life (QOL) questionnaires given to the patient at each visit
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343121
|The Christie NHS Foundation Trust|
|Manchester, Gtr Manchester, United Kingdom, M20 4BX|
|Principal Investigator:||Ananya Choudhury, Phd||The Christie NHS Foundation Trust|