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| Sponsored by: |
Light Sciences Oncology |
| Information provided by: | Light Sciences Oncology |
| ClinicalTrials.gov Identifier: | NCT00440310 |
Purpose
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, Snoqualmie, 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.
| Condition | Intervention | Phase |
|
Liver Metastases Colorectal Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local |
Drug: Talaporfin sodium Procedure: Percutaneous placement of device in liver metastases Device: Interstitial light emitting diodes Drug: FOLFOX4 OR FOLFIRI regimen |
Phase III |
| MedlinePlus related topics: | Cancer Colorectal Cancer Liver Cancer |
| Drug Information available for: | Monoaspartyl chlorin e6 Talaporfin sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 450 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Litx + Chemotherapy: Experimental |
Drug: Talaporfin sodium
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Procedure: Percutaneous placement of device in liver metastases
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.
Device: Interstitial light emitting diodes
200 J/cm per Light Source at 20 mW/cm light energy
Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens
|
| Chemotherapy alone: Active Comparator |
Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens
|
Randomized, stratified, two arm study:
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).
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |||||
| Landeskrankenhaus Feldkirch | Recruiting | ||||
| Feldkirch, Austria | |||||
| Contact: Alois Lang, MD alois.lang@lkhf.at | |||||
| Principal Investigator: Alois Lang, MD | |||||
| Bosnia and Herzegovina | |||||
| Clinical Centre of the University of Sarajevo, Institute of Oncology | Recruiting | ||||
| Sarajevo, Bosnia and Herzegovina | |||||
| Contact: Semir Bešlija, MD onkokcus@bih.net.ba | |||||
| Principal Investigator: Semir Bešlija, MD | |||||
| Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology | Recruiting | ||||
| Mostar, Bosnia and Herzegovina | |||||
| Contact: Milenko Bevanda, D.Sci daniela.bevanda@tel.net.ba | |||||
| Principal Investigator: Milenko Bevanda, D.Sci | |||||
| Croatia | |||||
| University Hospital Dubrava | Recruiting | ||||
| Zagreb, Croatia | |||||
| Contact: Zeljko Cabrijan, MD zeljko.cabrijan@zg.t-com.hr | |||||
| Principal Investigator: Milan Kujundži, MD, PhD | |||||
| Clinical Centre Zagreb, Clinical Oncology | Recruiting | ||||
| Zagreb, Croatia | |||||
| Contact: Zdenko Krajina, MD zdenko.krajina@gmail.com | |||||
| Principal Investigator: Zdenko Krajina, MD | |||||
| Germany | |||||
| Martin-Luther-Universität Halle-Wittenberg | Recruiting | ||||
| Halle, Germany | |||||
| Contact: Dirk Arnold, MD dirk.arnold@medizin.uni-halle.de | |||||
| Principal Investigator: Dirk Arnold, MD | |||||
| Johann Wolfgang Goethe Universitat | Recruiting | ||||
| Frankfurt, Germany | |||||
| Contact: Thomas Vogl, MD t.vogl@em.uni-frankfurt.de | |||||
| Principal Investigator: Thomas Vogl, MD | |||||
| Italy | |||||
| Azienda Ospedaliero-Universitaria Riunti | Recruiting | ||||
| Ancona, Italy | |||||
| Contact: Stefano Cascinu, MD s.cascinu@ao-umbertoprimo.marche.it | |||||
| Principal Investigator: Stefano Cascinu, MD | |||||
| Azienda Ospedaliera Universitaria Padovana | Recruiting | ||||
| Padova, Italy | |||||
| Contact: Fabio Farinati, MD fabio.farinati@unipd.it | |||||
| Principal Investigator: Fabio Farinati, MD | |||||
| Latvia | |||||
| Riga Eastern Hospital, Latvian Oncology Center | Recruiting | ||||
| Riga, Latvia | |||||
| Contact: Krumins Viesturs, MD viesturs@onkoc.mt.lv | |||||
| Principal Investigator: Krumins Viesturs, MD | |||||
| Poland | |||||
| Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej | Recruiting | ||||
| Łódź, Poland | |||||
| Contact: Anna Płużańska, MD apluzanska@o2.pl | |||||
| Principal Investigator: Anna Płużańska, MD | |||||
| Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego | Recruiting | ||||
| Warszawa, Poland | |||||
| Contact: Marek Nowacki, MD dyrektor@coi.waw.pl | |||||
| Principal Investigator: Marek Nowacki, MD | |||||
| Klinika Chirurgii Ogólnej i Onkologicznej | Recruiting | ||||
| Szczecin, Poland | |||||
| Contact: Józef Kładny, MD jkladny@sci.pam.szczecin.pl | |||||
| Principal Investigator: Józef Kładny, MD | |||||
| Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej | Recruiting | ||||
| Kraków, Poland | |||||
| Contact: Jan Kulig, MD mskulig@cyf-kr.edu.pl | |||||
| Principal Investigator: Jan Kulig, MD | |||||
| Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie | Recruiting | ||||
| Kraków, Poland | |||||
| Contact: Janusz Rolski, MD cht-krak@wp.pl | |||||
| Principal Investigator: Janusz Rolski, MD | |||||
| Klinika Chirurgii Onkologicznej | Recruiting | ||||
| Lublin, Poland | |||||
| Contact: Wojciech Polkowski, MD wojciech.polkowski@am.lublin.pl | |||||
| Principal Investigator: Wojciech Polkowski, MD | |||||
| Romania | |||||
| St. Spiridon University Emergency Hospital | Recruiting | ||||
| Iasi, Romania | |||||
| Contact: Tarcoveanu Eugen, MD etarco@iasi.mednet.ro | |||||
| Principal Investigator: Tarcoveanu Eugen, MD | |||||
| Fundeni Clinical Institute | Recruiting | ||||
| Bucharest, Romania | |||||
| Contact: Irinel Popescu, MD irinel.popescu@icfundeni.ro | |||||
| Principal Investigator: Irinel Popescu, MD | |||||
| Oncology Institute "Ion Chircuta" Cluj-Napoca | Recruiting | ||||
| Timisoara, Romania | |||||
| Contact: Ciuleanu Tudor-Eliade, MD, PhD tudor@iocn.ro | |||||
| Principal Investigator: Ciuleanu Tudor-Eliade, MD, PhD | |||||
| County Emergency Hospital Timisoara | Recruiting | ||||
| Timisoara, Romania | |||||
| Contact: Ioan Sporea, MD isporea@excite.com | |||||
| Principal Investigator: Ioan Sporea, MD | |||||
| Serbia | |||||
| Institute of Oncology and Radiology of Serbia | Recruiting | ||||
| Belgrade, Serbia | |||||
| Contact: Dusanka Jelecanin jelecanind@ncrc.ac.yu | |||||
| Principal Investigator: Ivan Popov, MD | |||||
| Institute of Oncology | Recruiting | ||||
| Sremska Kamenica, Serbia | |||||
| Contact: Matejasev Stanka matejasev.stanka@onko.onk.ns.ac.yu | |||||
| Principal Investigator: Dusan Jovanovic, MD, PhD | |||||
| Military Medical Academy | Recruiting | ||||
| Belgrade, Serbia | |||||
| Contact: Radoje Doder, MD doder@eunet.yu | |||||
| Principal Investigator: Radoje Doder, MD | |||||
| Slovakia | |||||
| St. Elizabeth Cancer Institute | Recruiting | ||||
| Bratislava, Slovakia | |||||
| Contact: Stanislav Špánik, MD sspanik@ousa.sk | |||||
| Principal Investigator: Stanislav Špánik, MD | |||||
| Sweden | |||||
| Karolinska University Hospital | Recruiting | ||||
| Stockholm, Sweden | |||||
| Contact: Ake Andren-Sandberg, MD ake.andren-sandberg@karolinska.se | |||||
| Principal Investigator: Ake Andren-Sandberg, MD | |||||
| Light Sciences Oncology |
| Study Director: | Sy-Shi Wang, PhD | Light Sciences Oncology |
More Information
| Responsible Party: | Light Sciences Oncology, Inc. ( Sy-Shi Wang/Study Director ) |
| Study ID Numbers: | LSO-OL006 |
| First Received: | February 23, 2007 |
| Last Updated: | November 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00440310 |
| Health Authority: | United States: Food and Drug Administration; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Croatia: Ministry of Health and Social Care; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Bosnia: Federal Ministry of Health; Latvia: State Agency of Medicines; Slovakia: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Romania: National Medicines Agency; Sweden: Medical Products Agency; Austria: Federal Office for Safety in Health Care |
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