Condition category
Cancer
Date applied
10/03/2005
Date assigned
27/04/2005
Last edited
04/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Stephen Pereira

ORCID ID

Contact details

Department of Gastroenterology
Middlesex Hospital
Mortimer Street
London
W1T 3AA
United Kingdom

Additional identifiers

EudraCT number

2005-001173-96

ClinicalTrials.gov number

NCT00513539

Protocol/serial number

PHOTOSTENT-02

Study information

Scientific title

Porfimer Sodium photodynamic therapy plus stenting versus stenting alone in patients with advanced or metastatic cholangiocarcinomas and other biliary tract tumours: a multicentre, randomised, phase ll/lll study

Acronym

PHOTOSTENT-02

Study hypothesis

The aim of this trial is to determine whether Photofrin® (profimer sodium) photodynamic therapy in addition to standard treatment confers an overall survival benefit in patients with locally advanced non-resectable biliary tract carcinoma. This is a multicentre, randomised, phase III trial, designed by members of the Trial Management Group in consultation with the National Cancer Research Institute (NCRI) Upper Gastrointestinal Clinical Studies Group. Patients entering the trial will be randomised to receive either a biliary stent or photodymanic therapy plus a stent. After 3 and 6 months patients will have a computed tomography (CT) scan to determine tumour response. After this patients will be seen as outpatients on a 3-monthly basis. CT scans and routine investigations will be performed at each outpatient visits. Patients who agree will complete quality of life questionnaires at baseline, and then again at 1, 3 and 6 months post-treatment.

Ethics approval

North West Multi-Centre REC, 20/06/2005, ref: 05/MRE08/32; CTA: 21266/0005/001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced or metastatic biliary tract cancer

Intervention

Randomisation between:
Arm A: Biliary stenting alone
Arm B: Biliary stenting plus photodynamic therapy

Please note that as of 18/01/10 this trial is closed to recruitment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Photofrin®

Primary outcome measures

Overall survival, i.e. death

Secondary outcome measures

1. Progression-free survival, measured by means of CT scanning carried out every three months until evidence of progression is identified
2. Toxicity, collected at baseline and 1 month post trial treatment for patients on the PDT arm we also collect toxicity data 7 days post-PDT treatment
3. Quality of life, collected at baseline 1, 3 and 6 months post-trial treatment

Overall trial start date

01/07/2005

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 16 years of age, either sex
2. Histologically/cytologically confirmed biliary tract carcinoma, unsuitable for surgery
3. Adequate biliary drainage
4. World Health Organization (WHO) performance score of 0, 1, 2 or 3
5. Life expectancy of greater than 12 weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400 (93 recruited in total, recruitment now closed [added 18/01/2010])

Participant exclusion criteria

1. Receiving concurrent treatment for metastatic disease
2. Other/prior malignancy or intercurrent disease
3. Unable to give consent
4. Shows symptoms of porphyria
5. Pregnant or lactating

Recruitment start date

07/07/2007

Recruitment end date

01/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Middlesex Hospital
London
W1T 3AA
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Industry

Funder name

Axcan Pharma Inc. (USA) - educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) - funding pending

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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