Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy (Gemtrans)
|ClinicalTrials.gov Identifier: NCT01343121|
Recruitment Status : Unknown
Verified January 2016 by Suzanne Rowland, The Christie NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : April 27, 2011
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Other: sample collection Other: Sample Collection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||January 2018|
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 Gemcitabine
Other: Sample Collection
Quality of Life (QOL) questionnaires given to the patient at each visit
- Does response at Cystoscopy correlate with results of sample analysis [ Time Frame: 3 months following the end of GemX chemoradiation ]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 ]
- acute and late toxicities as assessed by RTOG and LENT SOM scales [ Time Frame: 3 years ]Toxicity is measured using LENT-SOMA (patient-reported) and CTCAE v4.0 (clinical assessment) during treatment and at follow up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343121
|The Christie NHS Foundation Trust|
|Manchester, Gtr Manchester, United Kingdom, M20 4BX|
|Principal Investigator:||Ananya Choudhury, Phd||The Christie NHS Foundation Trust|