Bladder Cancer
Conditions
Keywords
Radiotherapy, GemX Chemoradiotherapy, Bladder Cancer
Brief summary
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.
Interventions
OTHERsample 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.
OTHERSample Collection
Quality of Life (QOL) questionnaires given to the patient at each visit
Sponsors
University of Oxford
The Christie NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma. * suitable for treatment with radical concurrent chemoradiotherapy with GemX. * Standard radiological assessments with CT or MR for staging. * ECOG performance status 0-2 * Adequate pre-treatment haematological and biochemical parameters * Age greater than or equal to 18 years * No significant co-morbidity thereby excluding patient from having radical treatment. * No previous treatment for diagnosis of muscle-invasive bladder cancer or other pelvic radiotherapy. * Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy * Patients must have given written informed consent
Exclusion criteria
* Patients with a known history of anaphylactic reaction to any other drug. * Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix * Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial. * Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial Any other serious uncontrolled medical conditions * Clinical evidence of metastatic disease to brain * Any pregnant or lactating woman * Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Does response at Cystoscopy correlate with results of sample analysis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cause-specific and overall survival rates | 3 years | — |
| acute and late toxicities as assessed by RTOG and LENT SOM scales | 3 years | Toxicity is measured using LENT-SOMA (patient-reported) and CTCAE v4.0 (clinical assessment) during treatment and at follow up. |
Countries
United Kingdom
Outcome results
None listed