This trial is active, not recruiting.

Condition bladder cancer
Treatments sample collection
Sponsor Christie Hospital NHS Foundation Trust
Collaborator University of Oxford
Start date January 2012
End date September 2015
Trial size 50 participants
Trial identifier NCT01343121, 10_DOG04_124


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
This is a single arm study. Patients will be seen on day 1, 8, 15 and 22 and will have the following samples collected: Pre gemcitabine urine sample Blood sample 30 minutes post Gemcitabine infusion Urine and blood sample 2 hours post Gemcitabine infusion
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.
sample collection
Urine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post Gemcitabine
sample collection
Quality of Life (QOL) questionnaires given to the patient at each visit

Primary Outcomes

Does response at Cystoscopy correlate with results of sample analysis
time frame: 3 months following the end of GemX chemoradiation

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy
Principal investigator Ananya Choudhury, Phd
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Christie Hospital NHS Foundation Trust.