Colorectal Neoplasms Clinical Trial
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
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.
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 ≤7.5 cm).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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