Back to resultsAdjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Adjuvant Chemotherapy
Radiographic surveillance
14-Gene Prognostic Assay
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Squamous, Adjuvant Chemotherapy, IFCT
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
Sites / Locations
- Highlands Oncology Group
- Leonard Cancer Institute
- UC Davis Comprehensive Cancer CenterRecruiting
- Providence Medical Foundation Santa RosaRecruiting
- Sarah Cannon- FCS SouthRecruiting
- Sarah Cannon- FCS NorthRecruiting
- Sarah Cannon- FCS PanhandleRecruiting
- Sarah Cannon- FCS EastRecruiting
- Baptist Health LexingtonRecruiting
- Baptist Health LouisvilleRecruiting
- Baptist Health Paducah
- Mercy Hospital Joplin Missouri
- Mercy Hospital South
- Mercy Oncology Research St. LouisRecruiting
- Hackensack Meridian HealthRecruiting
- Sarah Cannon- Messino Cancer CenterRecruiting
- Mercy Oncology Research Oklahoma City
- Allegheny Health Network Research InstituteRecruiting
- St. Francis Cancer CenterRecruiting
- Sarah Cannon Tennessee OncologyRecruiting
- Swedish Cancer InstituteRecruiting
- Toulon HIA Sainte Anne-Recruiting
- Polyclinique Bordeaux NordRecruiting
- Hôpital Charles NicolleRecruiting
- CHU d'Angers Service PneumologieRecruiting
- Centre Hospitalier de la Côte BasqueRecruiting
- CHRU Besançon- Hôpital J. MINJOZRecruiting
- Hôpital APHP Ambroise ParéRecruiting
- Hia Percy
- Centre Hospitalier Intercommunal de CréteilRecruiting
- Centre Hospitalier Départemental VendéeRecruiting
- Hôpital Privé Jean MermozRecruiting
- Hôpital EuropeenRecruiting
- Hôpital NordRecruiting
- Groupe Hospitalier Région de Mulhouse Sud -AlsaceRecruiting
- Centre Hospitalier Universitaire de NîmesRecruiting
- Hôpital CochinRecruiting
- Hôpital TenonRecruiting
- Hôpital Paris Saint JosephRecruiting
- Hôpital BichatRecruiting
- Hôpital Haut-Lévèque (Bordeaux - CHU)Recruiting
- Chu de PoitiersRecruiting
- Hôpital LarreyRecruiting
- CHRU de ToursRecruiting
- Gustave Roussy
- Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -Recruiting
- München-GautingRecruiting
- Niels-Stensen-KlinikenRecruiting
- Lung Clinic Grosshansdorf-Department of Thoracic OncologyRecruiting
- Köln-MerheimRecruiting
- Pius-Hospital Oldenburg Medizinischer Campus Universität OldenburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Observation
Adjuvant Chemotherapy
Arm Description
Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.
Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.
Outcomes
Primary Outcome Measures
Disease-Free Survival
To compare Disease Free Survival in patients with resected, stage I or IIA non-squamous NSCLC found to be at intermediate or high risk by the 14-Gene Prognostic Assay randomized to either observation or adjuvant therapy with 4 cycles of a platinum-based doublet.
Secondary Outcome Measures
Overall Survival
To compare Overall Survival in patients randomized to each study arm. To further document the previously verified separation of the survival curves among high and low risk patients identified by the 14-Gene Prognostic Assay in this prospective cohort of stage I or IIA non-squamous NSCLC.
Full Information
NCT ID
NCT01817192
First Posted
March 16, 2013
Last Updated
July 13, 2023
Sponsor
Razor Genomics
Collaborators
Encore Clinical
1. Study Identification
Unique Protocol Identification Number
NCT01817192
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 Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Razor Genomics
Collaborators
Encore Clinical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Squamous, Adjuvant Chemotherapy, IFCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Results of 14-Gene prognostic assay will not be revealed to the patient. Low risk patients will be observed, intermediate and high risk patients will be randomized to observation or four cycles of a platinum-based doublet therapy.
Allocation
Randomized
Enrollment
1050 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Active Comparator
Arm Description
Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.
Arm Title
Adjuvant Chemotherapy
Arm Type
Active Comparator
Arm Description
Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.
Intervention Type
Drug
Intervention Name(s)
Adjuvant Chemotherapy
Intervention Description
Patients who have undergone complete resection of NSCLC that has been documented histologically to be non-squamous and that is pathological Stage I or IIA, will undergo testing with the 14-Gene Prognostic Assay. Patients determined to be intermediate or high risk and who meet all eligibility criteria will be randomized either to observation or to four cycles of adjuvant therapy with a standard NSCLC platinum-based doublet.
Intervention Type
Other
Intervention Name(s)
Radiographic surveillance
Intervention Description
Serial radiographic surveillance is a current standard of care for Stage I or Stage IIA lung cancer. All intermediate or high risk patients randomized to observation or chemotherapy will have routine CT Scans at 6 month intervals until 5 years after enrollment and at yearly intervals thereafter until the end of the study period.
Intervention Type
Other
Intervention Name(s)
14-Gene Prognostic Assay
Intervention Description
This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of Stage I or Stage IIA non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as intermediate or high-risk will be randomized to either adjuvant chemotherapy or observation.
Primary Outcome Measure Information:
Title
Disease-Free Survival
Description
To compare Disease Free Survival in patients with resected, stage I or IIA non-squamous NSCLC found to be at intermediate or high risk by the 14-Gene Prognostic Assay randomized to either observation or adjuvant therapy with 4 cycles of a platinum-based doublet.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
To compare Overall Survival in patients randomized to each study arm. To further document the previously verified separation of the survival curves among high and low risk patients identified by the 14-Gene Prognostic Assay in this prospective cohort of stage I or IIA non-squamous NSCLC.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Mann, MD
Phone
650-535-0030
Email
mmann@encoreclinical.org
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Clary, RN
Phone
650-535-0030
Email
cclary@encoreclinical.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Spigel, MD
Organizational Affiliation
Sarah Cannon, The Cancer Institute of HCA Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Withdrawn
Facility Name
Leonard Cancer Institute
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92961
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Snoti A. Kumeh
Phone
916-734-3608
Email
sakumeh@ucdavis.ed
First Name & Middle Initial & Last Name & Degree
David R. Gandara, MD
Facility Name
Providence Medical Foundation Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Phillips
Phone
707-521-3833
Email
melissa.phillips2@stjoe.org
First Name & Middle Initial & Last Name & Degree
Tracy Foster
Phone
707 521 3833
Email
tracy.foster@stjoe.org
First Name & Middle Initial & Last Name & Degree
Ian Anderson, MD
Facility Name
Sarah Cannon- FCS South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Bentz
Email
lbentz@flcancer.com
First Name & Middle Initial & Last Name & Degree
Ivor Percent, MD
Facility Name
Sarah Cannon- FCS North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinah Welsh-Barnes
Phone
727-216-1143
Ext
13097
Email
diBarnes@flcancer.com
First Name & Middle Initial & Last Name & Degree
Vijay Patel, MD
Facility Name
Sarah Cannon- FCS Panhandle
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patty Wright
Phone
850-877-8166
Email
pwright@flcancer.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Bubis, MD
Facility Name
Sarah Cannon- FCS East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Bar-Nur, RN
Phone
561-472-1696
Email
jbar-nur@flcancer.com
First Name & Middle Initial & Last Name & Degree
Shachar Peles, MD
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karli Heasley, BPH
Phone
859-260-6464
Email
karli.heasley@BHSI.COM
First Name & Middle Initial & Last Name & Degree
Firas Badin, MD
First Name & Middle Initial & Last Name & Degree
Amy Schell, MD
First Name & Middle Initial & Last Name & Degree
Lee Hicks, MD
First Name & Middle Initial & Last Name & Degree
Arvinda Padmanabhan, MD
Facility Name
Baptist Health Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Strange
Phone
502-928-6103
Email
kelly.strange@bhsi.com
First Name & Middle Initial & Last Name & Degree
Renee Dickerson, RN, BSN, CCRC
Phone
502-928-6102
Email
renee.dickerson1@bhsi.com
First Name & Middle Initial & Last Name & Degree
Wangjian Zhong, MD, PhD
First Name & Middle Initial & Last Name & Degree
Leela Bhupalam, MD
First Name & Middle Initial & Last Name & Degree
James Code, MD
First Name & Middle Initial & Last Name & Degree
Khalid Ghosheh, MD
First Name & Middle Initial & Last Name & Degree
Andrew Hart, MD
First Name & Middle Initial & Last Name & Degree
John Huber, MD
Facility Name
Baptist Health Paducah
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mercy Hospital Joplin Missouri
City
Joplin
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mercy Oncology Research St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Cattoor
Email
Erin.Cattoor@mercy.net
First Name & Middle Initial & Last Name & Degree
Jessica Black
Email
Jessica.Black@mercy.net
First Name & Middle Initial & Last Name & Degree
Bethany Sleckman, MD
First Name & Middle Initial & Last Name & Degree
Hsiao-Ou Hu, MD
First Name & Middle Initial & Last Name & Degree
John Finnie, MD
First Name & Middle Initial & Last Name & Degree
Heide Rodgers, MD
First Name & Middle Initial & Last Name & Degree
Somasekhar Bandi, MD
First Name & Middle Initial & Last Name & Degree
Kavitha Kosuri, DO
Facility Name
Hackensack Meridian Health
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise M. Theiler, MSN,RN,CHPN,OCN
Phone
732-897-2871
First Name & Middle Initial & Last Name & Degree
Thomas Bauer, MD
Facility Name
Sarah Cannon- Messino Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Duckett
Phone
828-212-7021
Ext
65319
Email
josh.duckett@aoncology.com
First Name & Middle Initial & Last Name & Degree
Karen Smith
Phone
828-212-7021
Ext
65403
Email
Karen.Smith@aoncology.com
First Name & Middle Initial & Last Name & Degree
Christopher Chay, MD
Facility Name
Mercy Oncology Research Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Allegheny Health Network Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Schwarz, RN
Phone
412-592-8162
Email
meredith.schwarz@ahn.org
First Name & Middle Initial & Last Name & Degree
Benny Weksler, MD
Facility Name
St. Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Crowe
Phone
864-603-6220
Email
ashley_crowe2@bshsi.org
First Name & Middle Initial & Last Name & Degree
Robert D Siegel, MD
Facility Name
Sarah Cannon Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Callaway
Phone
615-329-7283
Email
brittany.callaway@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
David Spigel, MD
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Smith
Phone
206-265-2937
Email
andrew.smith@swedish.org
First Name & Middle Initial & Last Name & Degree
Renae Koepke
Phone
206-386-2441
Email
renae.koepke@swedish.org
First Name & Middle Initial & Last Name & Degree
Adam J Bograd, MD
First Name & Middle Initial & Last Name & Degree
Eric Vallieres, MD
First Name & Middle Initial & Last Name & Degree
Brian Louie, MD
First Name & Middle Initial & Last Name & Degree
Alex Farivar, MD
First Name & Middle Initial & Last Name & Degree
Ralph Aye, MD
Facility Name
Toulon HIA Sainte Anne-
City
Toulon
State/Province
Cedex 9
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Bylicki, MD
Facility Name
Polyclinique Bordeaux Nord
City
Bordeaux
State/Province
Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigolène Galland-Girodet, MD
Facility Name
Hôpital Charles Nicolle
City
Rouen
State/Province
Cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Guisier, MD
Facility Name
CHU d'Angers Service Pneumologie
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Hureaux, MD
Facility Name
Centre Hospitalier de la Côte Basque
City
Bayonne
ZIP/Postal Code
33077
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Schneider, MD
Facility Name
CHRU Besançon- Hôpital J. MINJOZ
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie Westeel, MD
Facility Name
Hôpital APHP Ambroise Paré
City
Boulogne
ZIP/Postal Code
92104
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Giroux Leprieur, MD
Facility Name
Hia Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé Le Floch, MD
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaelle Rousseau-Bussac, MD
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril Guibert, MD
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bombaron, MD
Facility Name
Hôpital Europeen
City
Marseille
ZIP/Postal Code
13291
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Le Treut, MD
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Greillier, MD
Facility Name
Groupe Hospitalier Région de Mulhouse Sud -Alsace
City
Mulhouse
ZIP/Postal Code
680100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Debieuvre, MD
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Van Hulst, MD
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Wislez, MD
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Cadranel, MD
Facility Name
Hôpital Paris Saint Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Jouveshomme, MD
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard Zalcman, MD
Facility Name
Hôpital Haut-Lévèque (Bordeaux - CHU)
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maéva Zysman, MD
Facility Name
Chu de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde Deldycke, MD
Facility Name
Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Mazieres, MD
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Legras, MD
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Besse, MD
Facility Name
Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -
City
Essen
ZIP/Postal Code
45239
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilfried Eberhardt, MD
First Name & Middle Initial & Last Name & Degree
Clemens Aigner, MD
Facility Name
München-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Reinmuth, MD
First Name & Middle Initial & Last Name & Degree
Thomas Dell, MD
Facility Name
Niels-Stensen-Kliniken
City
Georgsmarienhütte
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Weimer
First Name & Middle Initial & Last Name & Degree
Petra Hoffknecht, MD
Facility Name
Lung Clinic Grosshansdorf-Department of Thoracic Oncology
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Reck, MD
Facility Name
Köln-Merheim
City
Köln
ZIP/Postal Code
51109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva L Buchmeier, MD
Facility Name
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
City
Oldenburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Griesinger, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22285053
Citation
Kratz JR, He J, Van Den Eeden SK, Zhu ZH, Gao W, Pham PT, Mulvihill MS, Ziaei F, Zhang H, Su B, Zhi X, Quesenberry CP, Habel LA, Deng Q, Wang Z, Zhou J, Li H, Huang MC, Yeh CC, Segal MR, Ray MR, Jones KD, Raz DJ, Xu Z, Jahan TM, Berryman D, He B, Mann MJ, Jablons DM. A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international validation studies. Lancet. 2012 Mar 3;379(9818):823-32. doi: 10.1016/S0140-6736(11)61941-7. Epub 2012 Jan 27.
Results Reference
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PubMed Identifier
28645632
Citation
Woodard GA, Wang SX, Kratz JR, Zoon-Besselink CT, Chiang CY, Gubens MA, Jahan TM, Blakely CM, Jones KD, Mann MJ, Jablons DM. Adjuvant Chemotherapy Guided by Molecular Profiling and Improved Outcomes in Early Stage, Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Jan;19(1):58-64. doi: 10.1016/j.cllc.2017.05.015. Epub 2017 May 31.
Results Reference
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PubMed Identifier
23093159
Citation
Kratz JR, Van den Eeden SK, He J, Jablons DM, Mann MJ. A prognostic assay to identify patients at high risk of mortality despite small, node-negative lung tumors. JAMA. 2012 Oct 24;308(16):1629-31. doi: 10.1001/jama.2012.13551. No abstract available.
Results Reference
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Learn more about this trial
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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