Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Richard Cowan
ORCID ID
Contact details
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
+44 161 446 3332
richard.cowan@christie-tr.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1368
Study information
Scientific title
Phase II study of radiotherapy with concurrent weekly gemcitabine in muscle-invasive bladder cancer
Acronym
Study hypothesis
The aim of this prospective phase II trial was to determine the response of muscle invasive bladder cancer (MIBC) to concurrent chemoradiotherapy using weekly gemcitabine with four weeks' radiotherapy (RT) (GemX).
Ethics approval
South Manchester Local Research and Ethics Committee approved (ref: 03/SM/097)
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Bladder Cancer; Disease: Bladder (advanced)
Intervention
Each cycle of concurrent chemotherapy comprised 100 mg/m^2 gemcitabine given as an intravenous infusion over 30 minutes 2 - 4 hours before radiotherapy (RT) on day 1. Conformal radiotherapy using four fields and multi-leaf collimators was delivered to the whole bladder with a minimum 2 cm margin at the involved wall. A total dose of 52.5 Gy was given as 20 fractions within 28 days. Gemcitabine was administered once weekly during RT on days 1, 8, 15 and 22.
Study entry: Registration only
Intervention type
Drug
Phase
Phase II
Drug names
Gemcitabine
Primary outcome measures
Tumour response, measured three months after completion of treatment
Secondary outcome measures
1. Toxicity
2. Survival
Overall trial start date
01/07/2003
Overall trial end date
07/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically confirmed T2-3 N0M0 transitional cell carcinoma (TCC) of the bladder*
2. Life expectancy greater than 3 months
3. World Health Organization (WHO) performance status 0 2
4. Patients opting for bladder preservation who are able and motivated to comply with follow up
5. Maximal achievable transurethral resection of bladder tumour (TURBT)
6. Serum creatinine less than 1.5 x upper limit of normal (ULN)
7. Haemoglobin (Hb) greater than 10 g/dl, platelets greater than 100,000/mm^3, white cell count (WCC) greater than 2000/mm^3
8. Aged greater than 18 years
9. Provided informed consent
*Patients with TCC in whom biopsy fails to demonstrate histological evidence of muscle invasion but where magnetic resonance (MR) demonstrates unequivocal evidence of deep muscle invasion can be accepted for trial entry
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Planned sample size: 50
Participant exclusion criteria
1. Residual tumour with any unidimensional measurement greater than or equal to 7 cm following TURBT
2. Poor bladder function:
2.1. Any WHO bladder symptom score equalling 3 or greater than or equal to two bladder symptom scores equalling 2
2.2. Documented bladder capacity less than or equal to 200 ml
3. Abnormal liver function tests (LFT) (bilirubin greater than 1.3 x ULN, alkaline phosphatase greater than 5 x ULN, transaminases greater than 5 x ULN)
4. Previous radiotherapy to pelvis
5. More than one instillation of intravesical cytotoxic chemotherapy or immunotherapy
6. Any previous systemic chemotherapy
7. Radiotherapy planning target volume (PTV) greater than 1000cm^3
8. Any prior malignancy (excluding basal cell carcinoma [BCC])
9. Pre-existing medical conditions that preclude this treatment
10. Pregnant or breast-feeding
11. Not able to use appropriate and/or adequate contraception during and for 3 months after the study
Recruitment start date
01/07/2003
Recruitment end date
07/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Christie Hospital NHS Foundation Trust (UK)
Sponsor details
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Christie Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary