Radiotherapy with weekly gemcitabine (GEM)

ISRCTN	ISRCTN64153246
DOI	https://doi.org/10.1186/ISRCTN64153246
Secondary identifying numbers	1368

Submission date: 30/07/2010
Registration date: 30/07/2010
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-radiotherapy-and-gemcitabine-for-people-with-bladder-cancer

Contact information

Dr Richard Cowan
Scientific

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Phone	+44 161 446 3332
Email	richard.cowan@christie-tr.nwest.nhs.uk

Study information

Study design	Multicentre non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Phase II study of radiotherapy with concurrent weekly gemcitabine in muscle-invasive bladder cancer
Study objectives	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(s)	South Manchester Local Research and Ethics Committee approved (ref: 03/SM/097)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Gemcitabine
Primary outcome measure	Tumour response, measured three months after completion of treatment
Secondary outcome measures	1. Toxicity 2. Survival
Overall study start date	01/07/2003
Completion date	07/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Planned sample size: 50
Key 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
Key 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
Date of first enrolment	01/07/2003
Date of final enrolment	07/08/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

550 Wilmslow Road

Manchester
M20 4BX
United Kingdom

Sponsor information

Christie Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

550 Wilmslow Road
Manchester
M20 4BX
England
United Kingdom

Website	http://www.christie.nhs.uk/
"ROR"	https://ror.org/03v9efr22

Funders

Funder type

Hospital/treatment centre

Christie Hospital NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	20/02/2011		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
12/12/2017: Publication reference added.