Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy (Gemtrans)
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|ClinicalTrials.gov Identifier: NCT01343121|
Recruitment Status : Unknown
Verified January 2016 by Suzanne Rowland, Christie Hospital 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 GemcitabineOther: 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.
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): NCT01343121
|The Christie NHS Foundation Trust|
|Manchester, Gtr Manchester, United Kingdom, M20 4BX|
|Principal Investigator:||Ananya Choudhury, Phd||The Christie NHS Foundation Trust|