Lung Cancer Clinical Trial

Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Written informed consent

Age ≥ 18 years

Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy according to local institutional standards and likely compliance with follow-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).

Willing to be randomized to chemotherapy.

Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per 8th edition, TNM staging system)

Adequate tissue sample for the 14-Gene Prognostic Assay

Life expectancy excluding NSCLC diagnosis ≥ 5 years

ECOG performance status 0-1

Completely healed incisions

Study is for people with:

Lung Cancer

Estimated Enrollment:

1050

Study ID:

NCT01817192

Recruitment Status:

Recruiting

Sponsor:

Razor Genomics

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There are 48 Locations for this study

See Locations Near You

Highlands Oncology Group
Springdale Arkansas, 72762, United States More Info
Amie Wann
Contact
479-502-9289
[email protected]
Eric Schaefer, MD
Principal Investigator
Leonard Cancer Institute
Mission Viejo California, 92961, United States More Info
Joscelyn W. Green, RN, MSN, OCN
Contact
714-734-6214
[email protected]
Samer Kanaan, MD
Principal Investigator
George Miranda, MD
Sub-Investigator
Howard Cheng, MD
Sub-Investigator
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Snoti A. Kumeh
Contact
916-734-3608
[email protected]
David R. Gandara, MD
Principal Investigator
Providence Medical Foundation Santa Rosa
Santa Rosa California, 95403, United States More Info
Melissa Phillips
Contact
707-521-3833
[email protected]
Tracy Foster
Contact
707 521 3833
[email protected]
Ian Anderson, MD
Principal Investigator
Sarah Cannon- FCS South
Fort Myers Florida, 33916, United States More Info
Lynn Bentz
Contact
[email protected]
Ivor Percent, MD
Principal Investigator
Sarah Cannon- FCS North
Saint Petersburg Florida, 33705, United States More Info
Dinah Welsh-Barnes
Contact
727-216-1143
[email protected]
Vijay Patel, MD
Principal Investigator
Sarah Cannon- FCS Panhandle
Tallahassee Florida, 32308, United States More Info
Patty Wright
Contact
850-877-8166
[email protected]
Jeffrey Bubis, MD
Principal Investigator
Sarah Cannon- FCS East
West Palm Beach Florida, 33401, United States More Info
Jennifer Bar-Nur, RN
Contact
561-472-1696
[email protected]
Shachar Peles, MD
Principal Investigator
Baptist Health Lexington
Lexington Kentucky, 40503, United States More Info
Karli Heasley, BPH
Contact
859-260-6464
[email protected]
Firas Badin, MD
Principal Investigator
Amy Schell, MD
Sub-Investigator
Lee Hicks, MD
Sub-Investigator
Arvinda Padmanabhan, MD
Sub-Investigator
Baptist Health Louisville
Louisville Kentucky, 40207, United States
Baptist Health Paducah
Paducah Kentucky, 42003, United States More Info
Tammy Coursey
Contact
270-575-2413
[email protected]
Betty Kuiper
Contact
270-575-2928
[email protected]
Winston Chua, MD
Principal Investigator
Nicholas Lopez, MD
Sub-Investigator
Mercy Hospital Joplin Missouri
Joplin Missouri, 65804, United States More Info
Esmeralda Carillo
Contact
[email protected]
Leah Klink
Contact
[email protected]
Samir Dalia, MD
Principal Investigator
David Croy, MD
Sub-Investigator
Irving LaFrancis, MD
Sub-Investigator
Rana Hawamdeh, MD
Sub-Investigator
Mercy Hospital South
Saint Louis Missouri, 63128, United States
Mercy Oncology Research St. Louis
Saint Louis Missouri, 63141, United States More Info
Erin Cattoor
Contact
[email protected]
Jessica Black
Contact
[email protected]
Bethany Sleckman, MD
Principal Investigator
Hsiao-Ou Hu, MD
Sub-Investigator
John Finnie, MD
Sub-Investigator
Heide Rodgers, MD
Sub-Investigator
Somasekhar Bandi, MD
Sub-Investigator
Kavitha Kosuri, DO
Sub-Investigator
Hackensack Meridian Health
Neptune New Jersey, 07753, United States More Info
Denise M. Theiler, MSN,RN,CHPN,OCN
Contact
732-897-2871
Thomas Bauer, MD
Principal Investigator
Sarah Cannon- Messino Cancer Center
Asheville North Carolina, 28803, United States More Info
Josh Duckett
Contact
828-212-7021
[email protected]
Karen Smith
Contact
828-212-7021
[email protected]
Christopher Chay, MD
Principal Investigator
Mercy Oncology Research Oklahoma City
Oklahoma City Oklahoma, 73120, United States More Info
Sherry Freeland
Contact
[email protected]
Carla Kurkijian, MD
Principal Investigator
Jess Armor, MD
Sub-Investigator
Abby Bova, MD
Sub-Investigator
Jordan Morton, MD
Sub-Investigator
Sonia Varghese, MD
Sub-Investigator
Christopher Thompson, MD
Sub-Investigator
Allegheny Health Network Research Institute
Pittsburgh Pennsylvania, 15212, United States More Info
Meredith Schwarz, RN
Contact
412-592-8162
[email protected]
Benny Weksler, MD
Principal Investigator
St. Francis Cancer Center
Greenville South Carolina, 29607, United States More Info
Taylor Crowe
Contact
864-603-6220
[email protected]
Robert D Siegel, MD
Principal Investigator
Sarah Cannon Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Brittany Callaway
Contact
615-329-7283
[email protected]
David Spigel, MD
Principal Investigator
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Andrew Smith
Contact
206-265-2937
[email protected]
Renae Koepke
Contact
206-386-2441
[email protected]
Adam J Bograd, MD
Principal Investigator
Eric Vallieres, MD
Sub-Investigator
Brian Louie, MD
Sub-Investigator
Alex Farivar, MD
Sub-Investigator
Ralph Aye, MD
Sub-Investigator
Toulon HIA Sainte Anne-
Toulon Cedex 9, 83800, France More Info
Olivier Bylicki, MD
Principal Investigator
Polyclinique Bordeaux Nord
Bordeaux Cedex, , France More Info
Sigolène Galland-Girodet, MD
Principal Investigator
Hôpital Charles Nicolle
Rouen Cedex, 76031, France More Info
Florian Guisier, MD
Principal Investigator
CHU d'Angers Service Pneumologie
Angers , 49033, France More Info
Jose Hureaux, MD
Principal Investigator
Centre Hospitalier de la Côte Basque
Bayonne , 33077, France More Info
Sophie Schneider, MD
Principal Investigator
CHRU Besançon- Hôpital J. MINJOZ
Besancon , 25000, France More Info
Virginie Westeel, MD
Principal Investigator
Hôpital APHP Ambroise Paré
Boulogne , 92104, France More Info
Etienne Giroux Leprieur, MD
Principal Investigator
Hia Percy
Clamart , 92141, France More Info
Hervé Le Floch, MD
Principal Investigator
Centre Hospitalier Intercommunal de Créteil
Créteil , 94000, France More Info
Gaelle Rousseau-Bussac, MD
Principal Investigator
Centre Hospitalier Départemental Vendée
La Roche-sur-yon , 85925, France More Info
Cyril Guibert, MD
Principal Investigator
Hôpital Privé Jean Mermoz
Lyon , 69008, France More Info
Pierre Bombaron, MD
Principal Investigator
Hôpital Europeen
Marseille , 13291, France More Info
Jacques Le Treut, MD
Principal Investigator
Hôpital Nord
Marseille , 13915, France More Info
Laurent Greillier, MD
Principal Investigator
Groupe Hospitalier Région de Mulhouse Sud -Alsace
Mulhouse , 68010, France More Info
Didier Debieuvre, MD
Principal Investigator
Centre Hospitalier Universitaire de Nîmes
Nîmes , 30029, France More Info
Sylvie Van Hulst, MD
Principal Investigator
Hôpital Cochin
Paris , 75014, France More Info
Marie Wislez, MD
Principal Investigator
Hôpital Tenon
Paris , 75020, France More Info
Jacques Cadranel, MD
Principal Investigator
Hôpital Paris Saint Joseph
Paris , 75674, France More Info
Stéphane Jouveshomme, MD
Principal Investigator
Hôpital Bichat
Paris , 75877, France More Info
Gérard Zalcman, MD
Principal Investigator
Hôpital Haut-Lévèque (Bordeaux - CHU)
Pessac , 33604, France More Info
Maéva Zysman, MD
Principal Investigator
Chu de Poitiers
Poitiers , 86021, France More Info
Clotilde Deldycke, MD
Principal Investigator
Hôpital Larrey
Toulouse , 31059, France More Info
Julien Mazieres, MD
Principal Investigator
CHRU de Tours
Tours , 37044, France More Info
Antoine Legras, MD
Principal Investigator
Gustave Roussy
Villejuif , 94805, France More Info
Benjamin Besse, MD
Principal Investigator
Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -
Essen , 45239, Germany More Info
Wilfried Eberhardt, MD
Principal Investigator
Clemens Aigner, MD
Principal Investigator
Munich-Gauting -Thoracic Oncology Department Asklepios Lung Clinic
Gauting , 82131, Germany More Info
Niels Reinmuth, MD
Principal Investigator
München-Gauting
Gauting , 82131, Germany More Info
Niels Reinmuth, MD
Principal Investigator
Thomas Dell, MD
Principal Investigator
Niels-Stensen-Kliniken
Georgsmarienhütte , , Germany More Info
Nicole Weimer
Contact
Petra Hoffknecht, MD
Principal Investigator
Lung Clinic Grosshansdorf-Department of Thoracic Oncology
Grosshansdorf , 22927, Germany More Info
Martin Reck, MD
Principal Investigator
Köln-Merheim
Köln , 51109, Germany More Info
Eva L Buchmeier, MD
Principal Investigator
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
Oldenburg , , Germany More Info
Frank Griesinger, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

1050

Study ID:

NCT01817192

Recruitment Status:

Recruiting

Sponsor:


Razor Genomics

How clear is this clinincal trial information?

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