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Observational Study of Best Supportive Care With or Without Surgery, Chemo or Radiotherapy in Pts With Carcinoma of Lung

This study has been terminated.
(PI left institution. Insufficient enrollment for analysis.)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00822016
First received: January 13, 2009
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

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 ]

Enrollment: 25
Study Start Date: July 2007
Study Completion Date: March 2011
Primary Completion Date: December 2010 (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:

    1. Patients with histologically diagnosed lung cancer.
    2. Patients receiving therapy should have an ECOG/Zubrod/SWOG performance status of <3 at the time of the initiation of therapy.
    3. 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

Locations
United States, New Mexico
Universtiy of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Dennie Jones, M.D. University of New Mexico Cancer Center
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00822016     History of Changes
Other Study ID Numbers: INST 0701C
Study First Received: January 13, 2009
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013