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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.
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, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Talaporfin sodium, Percutaneous placement of device in liver metastases, Interstitial light emitting diodes, FOLFOX4 OR FOLFIRI regimen
Active, not recruiting
Light Sciences Oncology
Published on BioPortfolio: 2014-07-24T14:22:10-0400
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This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).
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A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
Percutaneous excision of a herniated or displaced intervertebral disk by posterolateral approach, always remaining outside the spinal canal. Percutaneous nucleotomy was first described by Hijikata in Japan in 1975. In 1985 Onik introduced automated percutaneous nucleotomy which consists in percutaneous aspiration of the nucleus pulposus. It is carried out under local anesthesia, thus reducing the surgical insult and requiring brief hospitalization, often performed on an outpatient basis. It appears to be a well-tolerated alternative to surgical diskectomy and chymopapain nucleolysis.
The sodium salt of BENZOIC ACID. It is used as an antifungal preservative in pharmaceutical preparations and foods. It may also be used as a test for liver function.
The sodium salts of the fatty acids in cod liver oil; an irritant and sclerosing agent used to treat varicose veins and arthritic joints.
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