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
EudraCT/CTIS number	2005-001173-96
ClinicalTrials.gov number	NCT00513539
Secondary identifying numbers	PHOTOSTENT-02

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

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

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 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(s)	North West Multi-Centre REC, 20/06/2005, ref: 05/MRE08/32; CTA: 21266/0005/001
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Photofrin®
Primary outcome measure	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 study start date	01/07/2005
Overall study end date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Both
Target number of participants	400
Total final enrolment	93
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 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

England
United Kingdom

Study participating centre

Middlesex Hospital

London
W1T 3AA
United Kingdom

Sponsor information

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Industry

Axcan Pharma Inc. (USA) - educational grant

No information available

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) - funding pending
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

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?
Results article	results	01/12/2012		Yes	No
Results article	results	23/07/2018		Yes	No
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.