Non-small Cell Lung Cancer Registry
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
3 other identifiers
interventional
300
1 country
101
Brief Summary
This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2004
Typical duration for phase_4
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 15, 2004
CompletedFirst Posted
Study publicly available on registry
December 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedNovember 23, 2009
November 1, 2009
December 15, 2004
November 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
Group 2: Observational
Secondary Outcomes (6)
Patients with an SRE will be evaluated for:
Time from stage IIIB/IV NSCLC diagnosis to progression to bone
Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
The effect of serum NTX levels on the development of skeletal events (SREs), and
Overall survival
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18 years
- Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
- Unresectable Stage IIIB with pleural effusion or stage IV NSCLC
- ECOG performance status of 0 or 1
You may not qualify if:
- Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)
- Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
- Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
- Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
- Abnormal renal function or creatinine clearance
- Unstable brain metastasis
- Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
- Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, 35205, United States
Hembree Cancer Center-St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72903, United States
Pacific Cancer Medical Center Inc.
Anaheim, California, 92801, United States
Bay Area Cancer Research Group
Concord, California, 94520, United States
Fresno Hem/Onc Medical Group
Fresno, California, 93720, United States
Beaver Med Group
Highland, California, 92346, United States
Redwood Regional Medical Group
Santa Rosa, California, 95403, United States
Stockton Hem. Onc.
Stockton, California, 95204, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80524, United States
Greeley Medical Clinic
Greeley, Colorado, 80631, United States
Western Hematology/Oncology
Lakewood, Colorado, 80215, United States
Hematology Oncology PC
Stamford, Connecticut, 06902, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Gainesville Hematology Oncology Associates
Gainesville, Florida, 32605, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Center for Cancer Care & Research
Lakeland, Florida, 33805, United States
Lake Heart & Cancer Center
Leesburg, Florida, 34748, United States
Melbourne Internal Medicine Assoc (MIMA) Century Research
Melbourne, Florida, 32901, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, 34652, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Mid- Florida Hematology & Oncology Centers, PA
Orange City, Florida, 32763, United States
Space Coast Medical
Titusville, Florida, 32796, United States
Vero Beach Hematology/Oncology
Vero Beach, Florida, 32960, United States
Hematology & Oncology of N.E. GA
Athens, Georgia, 30607, United States
Augusta Onc. Associates
Augusta, Georgia, 30901, United States
Suburban Hematology-Oncology
Snellville, Georgia, 30078, United States
Regional Cancer Center
Danville, Illinois, 61832, United States
The Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
Lekha Babu M.D Ltd.
Flossmoor, Illinois, 60422, United States
Joliet Oncology Hematology Associates, Ltd
Joliet, Illinois, 60435, United States
LaGrange Oncology Associates
LaGrange, Illinois, 60525, United States
Northwest Medical Specialists
Niles, Illinois, 60714, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
Kentuckiana Cancer Center, PLLC
Louisville, Kentucky, 40202, United States
W. Kentucky Hematology's Oncology Group, PSC
Paducah, Kentucky, 42003, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, 71301, United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506, United States
Hematology and Oncology Specialists
Metairie, Louisiana, 70006, United States
Highland Clinic, APMC
Shreveport, Louisiana, 71105, United States
Sinai Hospital
Baltimore, Maryland, 21215, United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, 21237, United States
David H. Smith, MD
Chestertown, Maryland, 21620, United States
Oncology-Hematology Associates, PA
Clinton, Maryland, 20735, United States
Maryland Oncology
Columbia, Maryland, 21044, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Caritas Holy Family Hospital
Methuen, Massachusetts, 01844, United States
Fallon Clinic
Worcester, Massachusetts, 01605, United States
Henry Ford Medical Center
Detroit, Michigan, 48202, United States
Singh & Arora Hematology/Oncology
Flint, Michigan, 48532, United States
Hubert Humphrey Cancer Center
Robbinsdale, Minnesota, 55442, United States
Heartland Hematology/Oncology Associates Inc.
Kansas City, Missouri, 64118, United States
St. Joseph Onocology, Inc.
Saint Joseph, Missouri, 64507, United States
University Hematology Oncology, Inc.
St Louis, Missouri, 63110, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Sierra Nevada Oncology Care
Carson City, Nevada, 89703, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
US Oncology
Las Vegas, Nevada, 89109, United States
Center For Cancer & Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
HOANNJ/Carol G. Simon Cancer Center
Morristown, New Jersey, 07960, United States
Medical Hematology/Oncology
Somerset, New Jersey, 08873, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057, United States
Huntington Medical Group
Huntington Station, New York, 11746, United States
Broome Oncology
Johnson City, New York, 13790, United States
Kin Yui Lam, MD
New York, New York, 10013, United States
Alamance Regional Medical Ctr. Cancer Ctr.
Burlington, North Carolina, 27215, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27609, United States
Summa Health System
Akron, Ohio, 44304, United States
OHCI
Cincinnati, Ohio, 45242, United States
Mukesh Bhatt, MD
Medina, Ohio, 44256, United States
Lawrence M. Stallings, MD, LLC
Wooster, Ohio, 44691, United States
M. Farouk Kanaa, MD, Inc.
Oklahoma City, Oklahoma, 73120, United States
Cancer Treatment Center
Tulsa, Oklahoma, 74133, United States
Oncology-Hematology of Lehigh Valley PC
Bethlehem, Pennsylvania, 18015, United States
Paul V. Woolley MD PC
Johnstown, Pennsylvania, 15905, United States
Chester County Hematology/Oncology Services
West Chester, Pennsylvania, 19380, United States
South Carolina Oncology Assoc., PA
Columbia, South Carolina, 29201, United States
Palmetto Hematology Oncology, P.C
Spartanburg, South Carolina, 29303-3041, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404, United States
The Family Cancer Center, PLLC
Collierville, Tennessee, 38017, United States
McLeod Cancer & Blood Center
Johnson City, Tennessee, 37604, United States
Kingsport Hematology-Oncology
Kingsport, Tennessee, 37660, United States
Eastern Connecticut Hematology/Oncology
Memphis, Tennessee, 38138, United States
Oncology Hematology of South Florida
Memphis, Tennessee, 38138, United States
The West Clinic
Memphis, Tennessee, 38138, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
St. Joseph Regional Cancer Ctr.
Bryan, Texas, 77802, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404, United States
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230, United States
Oncology Consultants P.A.
Houston, Texas, 77024, United States
South Texas Oncology & Hematology
San Antonio, Texas, 78258, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Cancer Outreach
Abingdon, Virginia, 24211, United States
Lynchburg Oncology
Lynchburg, Virginia, 24501, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Oncology/Hematology Association of SW VA
Roanoke, Virginia, 24104, United States
Western WA Med. Grp. Oncology
Everett, Washington, 98201, United States
Western Washington Oncology
Lacey, Washington, 98503, United States
Swedish Health Services
Seattle, Washington, 98104, United States
Oncology Alliance, S.C.
Glendale, Wisconsin, 53212, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
L. Lacerna, MD
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 15, 2004
First Posted
December 16, 2004
Study Start
November 1, 2004
Study Completion
November 1, 2007
Last Updated
November 23, 2009
Record last verified: 2009-11