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)

February 18, 2013 updated by: University College, London

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

RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.

PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To assess the efficacy, in terms of overall survival, of biliary stenting with vs without photodynamic therapy using porfimer sodium in advanced, recurrent, or metastatic biliary tract carcinoma.

Secondary

  • To evaluate the two treatments arms with respect to progression-free survival, toxicity using NCI Common Toxicity Criteria (version 3.0), and quality of life.

OUTLINE: This is a multicenter study. Patients are stratified by participating center, primary site (gallbladder vs bile duct), disease stage (locally advanced vs metastatic), prior therapy (i.e., surgery, radiotherapy or chemotherapy) (yes vs no), performance score (0 vs 1 vs 2 vs 3), and prior treatment arm on UK chemotherapy trial ABC-02 (gemcitabine hydrochloride alone vs gemcitabine hydrochloride and cisplatin). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients undergo either endoscopic or percutaneous drainage and insertion of unilateral or bilateral plastic endoprostheses above the main strictures of the right and left hepatic bile ducts.
  • Arm II: Patients undergo treatment as in arm I. Patients also receive porfimer sodium IV and then undergo laser activation 48 hours later.

After completion of study treatment, patients are followed every 3 months for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospital
      • London, England, United Kingdom, NW1 2PG
        • University College Hospital
      • Nottingham, England, United Kingdom, NG7 2UH
        • Queen's Medical Centre
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Biliary Stenting alone
Procedure: biliary stenting
Experimental: Arm B
Photodynamic Therapy plus biliary stenting
Procedure: biliary stenting
Drug: porfimer sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: minimum follow up 3 years or until death
minimum follow up 3 years or until death

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival every 3 months
Time Frame: minimum follow up 3 years or until death
minimum follow up 3 years or until death
Toxicity as assessed by NCI CTC v. 3.0
Time Frame: patients followed up for minimum of 3 years
patients followed up for minimum of 3 years
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
patients followed up for a minimum of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Study Chair: Stephen P. Pereira, MD, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimate)

August 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000558540
  • CRUK-PHOTOSTENT-02
  • EU-20740
  • EUDRACT-2005-001173-96
  • ISRCTN87712758
  • CTA-20363/0207/001-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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