Conditions: Liver Metastases Colorectal Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local
Keywords: Liver neoplasms Liver metastases MCRC Litx™ LS11 Colorectal cancer with recurrent liver metastases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 483
Healthy volunteers: no

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.

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 ≤7.5 cm).

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Talaporfin sodium intervention 2: Percutaneous placement of device in liver metastases intervention 3: Interstitial light emitting diodes intervention 4: FOLFOX4 regimen intervention 5: FOLFIRI regimen
Intervention descriptions: intervention 1: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes). intervention 2: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions. intervention 3: 200 J/cm per Light Source at 20 mW/cm light energy intervention 4: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin intervention 5: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan

Protocol document: