Spots Global Cancer Trial Database for Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
Official Title: A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study
Study ID: NCT01555710
Conditions
Study Description
Brief Summary: This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Birmingham Hematology and Oncology Associates, LLC, Birmingham, Alabama, United States
University of Southern California, Los Angeles, California, United States
Redwood Regional Oncology Group, Santa Rosa, California, United States
Christiana Care Health Services, Newark, Delaware, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port Sant Lucie, Florida, United States
Peachtree Hematology Oncology Consultants, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Medical and Surgical Specialists, LLC, Galesburg, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Central Indiana Cancer Centers, Fishers, Indiana, United States
Goshen Center for Cancer Care, Goshen, Indiana, United States
Indiana University, Indianapolis, Indiana, United States
Horizon Oncology Center, Lafayette, Indiana, United States
Indiana University Health Ball Memorial Hospital, Muncie, Indiana, United States
University of Kansas Hospital, Overland Park, Kansas, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Medical Oncology, LLC, Baton Rouge, Louisiana, United States
Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland, United States
Metro Health Cancer Center, Wyoming, Michigan, United States
Saint Mary's Medical Center, Duluth, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center, Morristown, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York Oncology Hematology, PC, Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
The Christ Hospital, Cincinnati, Ohio, United States
Dayton Cancer Center, Medical Oncology Hematology Associates, Dayton, Ohio, United States
Medical Oncology Associates Of Wyoming Valley, PC, Kingston, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
Texas Oncology-Medical City Dallas, Dallas, Texas, United States
Texas Oncology- Baylor, Charles A. Sammons Cancer Center, Dallas, Texas, United States
University of Texas Medical Branch at Galveston, Galveston, Texas, United States
Oncology Consultants, PA, Houston, Texas, United States
Texas Oncology, PA, Wichita Falls, Texas, United States
Fletcher Allen Health Care, Burlington, Vermont, United States
Fairfax Northern Virginia Hematology-Oncology, PC, Fairfax, Virginia, United States
Swedish Medical Center, Seattle, Washington, United States
Wisconsin Institutes for Medical Research, Madison, Wisconsin, United States
Southern Medical Day Oncology Care Centre, Wollongong, New South Wales, Australia
CancerCare Manitoba, Winnipeg, Manitoba, Canada
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Hôpital Laval, Sainte Foy, Quebec, Canada
Centre François Baclesse, Caen, Basse-normandie, France
Centre Hospitalier Universitaire -Hôpital Morvan, Brest, Bretagne, France
Centre Hospitalier Universitaire, Hopital Bretonneau, Tours cedex 1, Centre, France
Hôpital du Cluzeau, Limoges, Limousin, Lorraine, France
Institut de Cancérologie de l'Ouest - René Gauducheau, Saint Herblain, Pays de La Loire, France
Hôpital Saint Joseph, Marseille, Provence Alpes Cote D'azur, France
Centre Hospitalier Lyon Sud, Pierre Bénité, Rhone-alpes, France
Centre Paul Strauss, Strasbourg, , France
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Debrecen, Hajdu-bihar, Hungary
Mátrai Gyógyintézet, Mátraháza, Heves, Hungary
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Organization, Ein Kerem, Jerusalem, , Israel
Meir Hospital Sapir Medical Center, Kfar Saba, , Israel
Western Gallilee Medical Center, Nahariya, , Israel
Rabin Medical Center Beilinson Campus, Petah Tiqwa, , Israel
Istituto Nazionale per la Ricerca sul Cancro, Genova, , Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milano, , Italy
Presidio Ospedaliero S. Chiara, Trento, , Italy
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Wojewódzkie Centrum Onkologii, Gdansk, Pomorskie, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego, Szczecin, Zachodniopomorskie, Poland
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan, Ufa, Bashkortostan, Russian Federation
City Oncology Hospital # 62, Moscow Region, Moscow, Russian Federation
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk, Primorskiy, Russian Federation
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan, Kazan, Tatarstan, Russian Federation
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary", Chelaybinsk, , Russian Federation
Ivanovo Regional Oncology Centre, Ivanovo, , Russian Federation
Cancer Research Center n.a. N.N. Blokhin, Moscow, , Russian Federation
GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary, Nizhny Novgorod, , Russian Federation
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia", Saint Petersburg, , Russian Federation
Saint-Petersburg State Medical University n. a. I. P. Pavlov, Saint-Petersburg, , Russian Federation
State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital", Yaroslavl, , Russian Federation
China Medical University Hospital, Taichung, , Taiwan
Wythenshawe Hospital, Manchester, England, United Kingdom
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
