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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)

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ClinicalTrials.gov Identifier: NCT00513539
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : February 20, 2013
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE August 6, 2007
First Posted Date  ICMJE August 8, 2007
Last Update Posted Date February 20, 2013
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2013)
Overall survival [ Time Frame: minimum follow up 3 years or until death ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
Overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2013)
  • Progression-free survival every 3 months [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • Progression-free survival every 3 months
  • Toxicity as assessed by NCI CTC v. 3.0
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
Intervention  ICMJE
  • Drug: porfimer sodium
  • Procedure: biliary stenting
Study Arms  ICMJE
  • Active Comparator: Arm A
    Biliary Stenting alone
    Intervention: Procedure: biliary stenting
  • Experimental: Arm B
    Photodynamic Therapy plus biliary stenting
    Interventions:
    • Drug: porfimer sodium
    • Procedure: biliary stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2013)
92
Original Enrollment  ICMJE
 (submitted: August 6, 2007)
240
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00513539
Other Study ID Numbers  ICMJE CDR0000558540
CRUK-PHOTOSTENT-02
EU-20740
EUDRACT-2005-001173-96
ISRCTN87712758
CTA-20363/0207/001-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Stephen P. Pereira, MD University College London Hospitals
PRS Account University College, London
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP