Clinical trialNCT00863512TerminatedPhase 3Interventional

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

SponsorAlliance for Clinical Trials in OncologyEnrollment34Lung Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David H. Harpole, MD
Duke Cancer Institute
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

94 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

St. Vincent'S Hospital - Melbourne
Fitzroy, Victoria, Australia

United States

Regional Medical Center
Anniston, Alabama, United States
Uab Comprehensive Cancer Center
Birmingham, Alabama, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States
Rebecca and John Moores Ucsd Cancer Center
La Jolla, California, United States
Facility name not stated
Pismo Beach, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
Ccop - Mount Sinai Medical Center
Miami Beach, Florida, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph'S/candler
Savannah, Georgia, United States
Resurrection Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Elkhart Clinic, Llc
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Michiana Hematology-Oncology, Pc - Elkhart
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at Laporte Hospital and Health Services
La Porte, Indiana, United States
Michiana Hematology-Oncology, Pc - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology Pc - Plymouth
Plymouth, Indiana, United States
Ccop - Northern Indiana Cr Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology Pc - la Porte
Westville, Indiana, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
Cancer Institute at St. Joseph Medical Center
Towson, Maryland, United States
Dana-Farber/brigham and Women'S Cancer Center
Boston, Massachusetts, United States
Dana-Farber/harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States

54 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cisplatin →Docetaxel →Gemcitabine →Pemetrexed →Vinorelbine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2009
Primary completion: 30 Nov 2011
Completion: 30 Nov 2012
Last update posted: 27 Mar 2017
Registered enrollment: 34
Registry id: NCT00863512

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.