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Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases

2014-07-24 14:22:10 | BioPortfolio

Summary

The purpose of the study is to assess the progression free survival and overall 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.

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 ≤7.5 cm).

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Metastases

Intervention

Talaporfin sodium, Percutaneous placement of device in liver metastases, Interstitial light emitting diodes, FOLFOX4 OR FOLFIRI regimen

Location

Landeskrankenhaus Feldkirch
Feldkirch
Karnataka
Austria

Status

Active, not recruiting

Source

Light Sciences Oncology

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:22:10-0400

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