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| Descriptive Information Fields | |||||
| Brief 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 | ||||
| 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 | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized | ||||
| Primary Outcome Measure † | Overall survival [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Progression-free survival every 3 months [ Designated as safety issue: No ] Toxicity as assessed by NCI CTC v. 3.0 [ Designated as safety issue: Yes ] 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 [ Designated as safety issue: No ] |
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| Condition † | Extrahepatic Bile Duct Cancer Gallbladder Cancer |
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| Intervention † | Drug: porfimer sodium Procedure: biliary stenting |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 240 | ||||
| Start Date † | July 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS: Inclusion criteria:
Exclusion criteria:
PATIENT CHARACTERISTICS: Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY: Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00513539 | ||||
| Organization ID | CDR0000558540 | ||||
| Secondary IDs †† | CRUK-PHOTOSTENT-02, EU-20740, EUDRACT-2005-001173-96, ISRCTN87712758, CTA-20363/0207/001-0001 | ||||
| Study Sponsor † | University College London Hospitals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | August 6, 2007 | ||||
| Last Updated Date | August 26, 2008 | ||||