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Sponsored by: |
University College London Hospitals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00513539 |
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.
Condition | Intervention | Phase |
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Extrahepatic Bile Duct Cancer Gallbladder Cancer |
Drug: porfimer sodium Procedure: biliary stenting |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official 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 |
Estimated Enrollment: | 240 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
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 may have received prior radiotherapy within the past 28 days (with or without radio-sensitizing low-dose chemotherapy) for localized disease and fully recovered
Patients may have received prior chemotherapy within the past 28 days and fully recovered
Exclusion criteria:
United Kingdom, England | |
Aintree University Hospital | Recruiting |
Liverpool, England, United Kingdom, L9 7AL | |
Contact: Richard Sturgess, MD 44-151-529-2814 | |
Queen's Medical Centre | Recruiting |
Nottingham, England, United Kingdom, NG7 2UH | |
Contact: Krish Ragunath, MD 44-115-924-9924 | |
University College Hospital | Recruiting |
London, England, United Kingdom, NW1 2PG | |
Contact: Stephen P. Pereira, MD 44-845-155-5000 stephen.pereira@ucl.ac.uk | |
United Kingdom, Scotland | |
Ninewells Hospital | Recruiting |
Dundee, Scotland, United Kingdom, DD1 9SY | |
Contact: Iain Tait, MD 44-1382-660-111 |
Study Chair: | Stephen P. Pereira, MD | University College London Hospitals |
Study ID Numbers: | CDR0000558540, CRUK-PHOTOSTENT-02, EU-20740, EUDRACT-2005-001173-96, ISRCTN87712758, CTA-20363/0207/001-0001 |
Study First Received: | August 6, 2007 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00513539 |
Health Authority: | Unspecified |
unresectable gallbladder cancer recurrent gallbladder cancer cholangiocarcinoma of the gallbladder |
unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer cholangiocarcinoma of the extrahepatic bile duct |
Bile duct cancer, extrahepatic Gallbladder Diseases Cholangiocarcinoma Biliary Tract Neoplasms Digestive System Neoplasms Recurrence Gall bladder cancer Carcinoma Digestive System Diseases |
Dihematoporphyrin Ether Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Trioxsalen Adenocarcinoma Neoplasms, Glandular and Epithelial |
Photosensitizing Agents Neoplasms Neoplasms by Histologic Type Neoplasms by Site Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |