Lung Cancer Clinical Trial; An Observational Study of Standard Practice of Best Supportive Care With or Without Surgery, Chemotherapy or Radiotherapy in Patients With Carcinoma of Lung

An Observational Study of Standard Practice of Best Supportive Care With or Without Surgery, Chemotherapy or Radiotherapy in Patients With Carcinoma of Lung
This study is currently recruiting participants.
Verified by University of New Mexico, January 2009
Sponsored by: University of New Mexico

Information provided by: University of New Mexico
ClinicalTrials.gov Identifier: NCT00822016

Purpose
The purpose of this study is to establish a listing (database) of patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites. The information will be used to determine the results of various treatments for lung cancer subjects and to find where improvements can be made in safety, effectiveness, supportive care, treatment that eases tumors without curing them, treatments that cure tumors, prevention, and follow-up efforts. The database information will be compared to clinical trial data published in peer-reviewed journals and SEER outcome data. Patients will be acquired both before and after they are treated for lung cancer.

Condition
Lung Cancer
Carcinoma of Lung

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: INST 0701C: An Observational Outcomes Protocol of Standard Practice of Best Supportive Care With or Without Surgery, Chemotherapy or Radiotherapy in Patients With Carcinoma of the Lung

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
To document the progression-free survival, rate of response, median duration of response, & median overall survivals, of subjects receiving best supportive care with or without standard surgery, chemotherapy and/or radiation therapy for lung cancer [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
To document the incidence and severity of toxicities, and reversibility of toxicities of subjects as a function of the treatments rendered. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: July 2007
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:
Same as above.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population
Patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites.

Criteria
Inclusion Criteria:

Those who are eligible for this treatment protocol will consist of:

Patients with histologically diagnosed lung cancer.
Patients receiving therapy should have an ECOG/Zubrod/SWOG performance status of <3 at the time of the initiation of therapy.
All newly diagnosed patients referred to an NMCC Alliance site will be eligible, as will patients with recurrent disease that are now referred to an NMCCA for their next therapy (such as those who move from out of state, or are referred for protocol therapy), though efforts will be made to obtain records of prior therapy administered elsewhere).
Exclusion Criteria:

Patients not falling under any of the above criteria are not eligible for the study.
Withdrawal of the informed consent at any point in the study excludes patient from the study.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822016

Contacts
Contact: Leanne Gideon 505-272-7090 LGideon@salud.unm.edu

Locations
United States, New Mexico
Universtiy of New Mexico - Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-0001
Contact: Leanne Gideon 505-272-7090 LGideon@salud.unm.edu
Principal Investigator: Dennie Jones, M.D.

Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Dennie Jones, M.D. University of New Mexico

More Information

Responsible Party: Universtiy of New Mexico - Cancer Center ( Dennie Jones )
Study ID Numbers: INST 0701C
Study First Received: January 13, 2009
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00822016 [history]
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Best Supportive Care
Protocol of Standard Practice
Carcinoma of the Lung

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 10, 2009

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