Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513539
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2007-08-06
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
Sponsor:
University College London
Organization:
University College London
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Photostent-02
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
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 30 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 ie 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
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 30 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTA-203630207001-0001 | None | None | None |
| CRUK-PHOTOSTENT-02 | None | None | None |
| EU-20740 | None | None | None |
| EUDRACT-2005-001173-96 | None | None | None |
| ISRCTN87712758 | None | None | None |