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

NCT00822016 | Terminated DMC

• 1 other identifier: INST 0701C
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Best Supportive Care; Protocol of Standard Practice; Carcinoma of the Lung

Outcome Measures

Primary Outcomes (1)

• 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

  3-6 months

Secondary Outcomes (1)

• To document the incidence and severity of toxicities, and reversibility of toxicities of subjects as a function of the treatments rendered.

  3-6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (2)

University of New Mexico Cancer Center @ Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Universtiy of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dennie Jones, M.D.

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: July 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: June 29, 2012

Record last verified: 2012-06

Locations

US (2)