Biliary stenting with or without photodynamic therapy in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinomas or other biliary tract tumours that cannot be removed by surgery

ISRCTN	ISRCTN87712758
DOI	https://doi.org/10.1186/ISRCTN87712758
ClinicalTrials.gov (NCT)	NCT00513539
Clinical Trials Information System (CTIS)	2005-001173-96
Protocol serial number	PHOTOSTENT-02
Sponsor	University College London (UK)
Funders	Axcan Pharma Inc. (USA) - educational grant, Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) - funding pending

Submission date: 10/03/2005
Registration date: 27/04/2005
Last edited: 11/07/2023

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-having-a-stent-with-or-without-photodynamic-therapy-for-symptoms-of-advanced-biliary-tract-cancer

Contact information

Dr Stephen Pereira
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PHOTOSTENT-02
Study objectives	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(s)	North West Multi-Centre REC, 20/06/2005, ref: 05/MRE08/32; CTA: 21266/0005/001
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Photofrin®
Primary outcome measure(s)	Overall survival, i.e. death
Key secondary outcome measure(s)	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
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	400
Total final enrolment	93
Key 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
Key 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
Date of first enrolment	07/07/2007
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Middlesex Hospital

London
W1T 3AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No
Results article	results	23/07/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			11/07/2023	No	Yes

Editorial Notes

11/07/2023: Results in plain English added to the study outputs table.
13/08/2018: Publication reference added.
04/10/2017: Publication reference added.