Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 25 February 2013
• Main ID: NCT00513539
• Date of registration: 06/08/2007
• Primary sponsor: University College, London
• Public title: Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery Photostent-02
• 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 Lll Study
• Date of first enrolment: July 2007
• Target sample size: 92
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00513539
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Stephen P. Pereira, MD
• Affiliation: University College London Hospitals

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

- Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent,
or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder
carcinoma

- Adequate biliary drainage, with no evidence of active uncontrolled infection
(patients on antibiotics are eligible)

Exclusion criteria:

- Porphyria

- No brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

- ECOG performance status 0, 1, 2, or 3

- Estimated life expectancy > 3 months

- Women of child-bearing potential should have a negative pregnancy test prior to study
entry AND be using an adequate contraception method, which must be continued for 1
month after completion of treatment

- Not pregnant or nursing

Exclusion criteria:

- History of prior malignancy that will interfere with the response evaluation
(exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection,
non-metastatic basal and/or squamous cell carcinomas of the skin, or any early stage
(stage l) malignancy adequately resected for cure greater than 5 years previously)

- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that
in the view of the investigator makes it undesirable for the patient to participate
in the trial

- Any psychiatric or other disorder likely to impact on informed consent

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- Patients may have undergone a non-curative operation (i.e., R2 resection [with
macroscopic residual disease] or palliative bypass surgery only) and fully recovered

- Patients who have previously undergone curative surgery must have evidence of
non-resectable disease relapse

- Patients may have received prior radiotherapy within the past 28 days (with or
without radio-sensitizing low-dose chemotherapy) for localized disease and fully
recovered

- Must have clear evidence of disease progression prior to inclusion in this study

- Patients may have received prior chemotherapy within the past 28 days and fully
recovered

- Must have clear evidence of disease progression prior to inclusion in this study

Exclusion criteria:

- Previous treatment with curative intent for current disease in the last 12 weeks
(i.e., prior resection, radical radiotherapy, or chemotherapy)

- Previous treatment with experimental therapy for current disease in the last 12 weeks

- No cytotoxic chemotherapy, radiotherapy, immunotherapy, hormonal therapy (excluding
contraceptives and replacement steroids), or experimental medications will be
permitted for the first four weeks of the study



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Extrahepatic Bile Duct Cancer

Gallbladder Cancer

Intervention(s)

Drug: porfimer sodium

Procedure: biliary stenting

Primary Outcome(s)

Overall survival [Time Frame: minimum follow up 3 years or until death]

Secondary Outcome(s)

Progression-free survival every 3 months [Time Frame: minimum follow up 3 years or until death]

Quality of life as assessed by EORTC QLQ 30 and PAN 26 at baseline and 1, 3, and 6 months after completion of study treatment [Time Frame: patients followed up for a minimum of 3 years]

Toxicity as assessed by NCI CTC v. 3.0 [Time Frame: patients followed up for minimum of 3 years]

Secondary ID(s)

CDR0000558540

CRUK-PHOTOSTENT-02

CTA-20363/0207/001-0001

EU-20740

EUDRACT-2005-001173-96

ISRCTN87712758

Source(s) of Monetary Support

Please refer to primary and secondary sponsors