Condition category
Cancer
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.christie.nhs.uk/

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

Publication citations

Additional files

Editorial Notes