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

PHASE3CompletedINTERVENTIONAL
Enrollment

483

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

May 31, 2011

Study Completion Date

October 31, 2011

Conditions
Liver MetastasesColorectal NeoplasmsNeoplasm MetastasisNeoplasm Recurrence, Local
Interventions
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 regimen

Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin

DRUG

FOLFIRI regimen

Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan

Trial Locations (57)

Unknown

Landeskrankenhaus Feldkirch, Feldkirch

Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel, Vienna

Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology, Mostar

Clinical Centre of the University of Sarajevo, Institute of Oncology, Sarajevo

General Hospital Karlovac, Karlovac

Clinical Centre Zagreb, Clinical Oncology, Zagreb

"General Hospital Sveti Duh", Zagreb

University Hospital Dubrava, Zagreb

Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I, Aalen

Helios Kliniken - Innere Medizin und Kardiologie, Borna

Katholisches Krankenhaus St. Johann Nepomuk, Erfurt

Johann Wolfgang Goethe Universitat, Frankfurt

Kliniken Ludwigsburg Bietigheim, Ludwigsburg

Bangalore Institute of Oncology, Bangalore

Mahavir Cancer Sansthan, Phulwarisharif

CIIGMA Institute of Medical Sciences, Aurangabad

Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal

SEAROC Cancer Center, S. K. Soni hospital, Jaipur

Shatabdi Super Specialty Hospital, Mumbai

Cancer Clinic, Shreevardhan complex, Nagpur

Ruby Hall Clinic, Pune

Azienda Ospedaliero-Universitaria Riunti, Ancona

Azienda Ospedaliera Careggi U.O. Oncologia Medica, Florence

Azienda Ospedaliera Universitaria Padovana, Padua

Policlinico Tor Vergata - Oncologia Medica, Rome

Riga Eastern Hospital, Latvian Oncology Center, Riga

Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie, Krakow

Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej, Krakow

Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej, Lodz

Klinika Chirurgii Onkologicznej, Lublin

Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii, Olsztyn

Klinika Chirurgii Ogólnej i Onkologicznej, Szczecin

Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego, Warsaw

Fundeni Clinical Institute, Bucharest

"Oncology Institute Ion Chircuta", Cluj-Napoca

St. Spiridon University Emergency Hospital, Iași

"State Institution Altay Territorial Oncological Dispensary", Barmaul

Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation, Moscow

Municipal Cliical Hospital # 33 named after Ostroumov, Moscow

Russian Oncological Scientific Center named after Blokhin, Moscow

Privolzhsky District Medical Center, Nizhny Novgorod

Central Research Institute of Roentgenology and Radiology, Saint Petersburg

Scientific Research Institution of Oncology, Saint Petersburg

"State Educational Institution of High Professional Education Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia", Saint Petersburg

Tambov Regional Oncological Dispensary, Tambov

"State Healthcare Institution of Yaroslavl region, Regional clinical oncological hospital", Yaroslavl

"State Healthcare Institution Sverdlovsk' Regional Oncological Dispensary", Yekaterinburg

Institute of Oncology and Radiology of Serbia, Belgrade

Military Medical Academy, Belgrade

Institute of Oncology, Kamenitz

Karolinska University Hospital, Stockholm

"Municipal Institution Cherkassy Regional Oncological Dispensary of Cherkassy", Cherkassy

Municipal Multiple-Discipline Clinical Hospital #4, Dnipro

Donetsk Cancer Centre, Donetsk

Kharkov Regional Clinical Oncology Dispansery, Kharkiv

The Central Hospital of the Ministry of Defense, Kyiv

Zaporozhye Medical Academy for postgraduate education, Zaporizhzhya

Sponsors
All Listed Sponsors
lead

Light Sciences Oncology

INDUSTRY

NCT00440310 - Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases | Biotech Hunter | Biotech Hunter