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.
Brief Title: Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer
Official Title: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as Intermediate or High Risk by a 14-Gene Prognostic Assay
Study ID: NCT01817192
Brief Summary: The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Springdale, Arkansas, United States
Leonard Cancer Institute, Mission Viejo, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Providence Medical Foundation Santa Rosa, Santa Rosa, California, United States
Sarah Cannon- FCS South, Fort Myers, Florida, United States
Sarah Cannon- FCS North, Saint Petersburg, Florida, United States
Sarah Cannon- FCS Panhandle, Tallahassee, Florida, United States
Sarah Cannon- FCS East, West Palm Beach, Florida, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Baptist Health Louisville, Louisville, Kentucky, United States
Baptist Health Paducah, Paducah, Kentucky, United States
Mercy Hospital Joplin Missouri, Joplin, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Mercy Oncology Research St. Louis, Saint Louis, Missouri, United States
Hackensack Meridian Health, Neptune, New Jersey, United States
Sarah Cannon- Messino Cancer Center, Asheville, North Carolina, United States
Mercy Oncology Research Oklahoma City, Oklahoma City, Oklahoma, United States
Allegheny Health Network Research Institute, Pittsburgh, Pennsylvania, United States
St. Francis Cancer Center, Greenville, South Carolina, United States
Sarah Cannon Tennessee Oncology, Nashville, Tennessee, United States
Swedish Cancer Institute, Seattle, Washington, United States
Toulon HIA Sainte Anne-, Toulon, Cedex 9, France
Polyclinique Bordeaux Nord, Bordeaux, Cedex, France
Hôpital Charles Nicolle, Rouen, Cedex, France
CHU d'Angers Service Pneumologie, Angers, , France
Centre Hospitalier de la Côte Basque, Bayonne, , France
CHRU Besançon- Hôpital J. MINJOZ, Besancon, , France
Hôpital APHP Ambroise Paré, Boulogne, , France
Hia Percy, Clamart, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre Hospitalier Départemental Vendée, La Roche-sur-yon, , France
Hôpital Privé Jean Mermoz, Lyon, , France
Hôpital Europeen, Marseille, , France
Hôpital Nord, Marseille, , France
Groupe Hospitalier Région de Mulhouse Sud -Alsace, Mulhouse, , France
Centre Hospitalier Universitaire de Nîmes, Nîmes, , France
Hôpital Cochin, Paris, , France
Hôpital Tenon, Paris, , France
Hôpital Paris Saint Joseph, Paris, , France
Hôpital Bichat, Paris, , France
Hôpital Haut-Lévèque (Bordeaux - CHU), Pessac, , France
Chu de Poitiers, Poitiers, , France
Hôpital Larrey, Toulouse, , France
CHRU de Tours, Tours, , France
Gustave Roussy, Villejuif, , France
Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -, Essen, , Germany
München-Gauting, Gauting, , Germany
Niels-Stensen-Kliniken, Georgsmarienhütte, , Germany
Lung Clinic Grosshansdorf-Department of Thoracic Oncology, Grosshansdorf, , Germany
Köln-Merheim, Köln, , Germany
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg, Oldenburg, , Germany
Name: David R Spigel, MD
Affiliation: Sarah Cannon, The Cancer Institute of HCA Healthcare
Role: PRINCIPAL_INVESTIGATOR