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Spots Global Cancer Trial Database for Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: David R Spigel, MD

Affiliation: Sarah Cannon, The Cancer Institute of HCA Healthcare

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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