Radiotherapy with weekly gemcitabine (GEM)
| ISRCTN | ISRCTN64153246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64153246 |
| Protocol serial number | 1368 |
| Sponsor | Christie Hospital NHS Foundation Trust (UK) |
| Funder | Christie Hospital NHS Foundation Trust (UK) |
- 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
Contact information
Dr Richard Cowan
Scientific
Scientific
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
| Phone | +44 161 446 3332 |
|---|---|
| richard.cowan@christie-tr.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Gemcitabine |
| Primary outcome measure(s) |
Tumour response, measured three months after completion of treatment |
| Key secondary outcome measure(s) |
1. Toxicity |
| Completion date | 07/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/02/2011 | Yes | No | |
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
12/12/2017: Publication reference added.
