Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440310
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2007-02-23
Brief Title:
Phase 3 Trial of Litx Plus Chemotherapy vs Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Sponsor:
Light Sciences Oncology
Organization:
Light Sciences Oncology
Study Overview
Official Title:
A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx System Plus Chemotherapy as Compared to Chemotherapy Only
Status:
COMPLETED
Status Verified Date:
2015-07
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:
None
Brief Summary:
The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases and to demonstrate the safety of Litx therapy
Litx consists of a light-activated drug talaporfin sodium LS11 Light Sciences Oncology Bellevue Washington and a light generating device composed of light-emitting diodes LEDs that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body
Litx consists of a light-activated drug talaporfin sodium LS11 Light Sciences Oncology Bellevue Washington and a light generating device composed of light-emitting diodes LEDs that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body
Detailed Description:
Randomized stratified two arm study
Litx and chemotherapy arm FOLFOX4 or FOLFIRI
Chemotherapy only arm FOLFOX4 or FOLFIRI
For patients who have progressed on FOLFIRI they will be treated with Litx plus FOLFOX4 versus FOLFOX4 alone and for patients who have progressed on FOLFOX they will be treated with Litx plus FOLFIRI versus FOLFIRI alone
Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter SLD SLD 4 cm or SLD 4 cm but 75 cm
Litx and chemotherapy arm FOLFOX4 or FOLFIRI
Chemotherapy only arm FOLFOX4 or FOLFIRI
For patients who have progressed on FOLFIRI they will be treated with Litx plus FOLFOX4 versus FOLFOX4 alone and for patients who have progressed on FOLFOX they will be treated with Litx plus FOLFIRI versus FOLFIRI alone
Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter SLD SLD 4 cm or SLD 4 cm but 75 cm
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