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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00822016
• Other study ID #: INST 0701C
• Status: Terminated
• Phase: N/A
• First received: January 13, 2009
• Last updated: June 27, 2012
• Start date: July 2007
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Same as above.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center @ Lovelace Medical Center	Albuquerque	New Mexico
United States	Universtiy of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To document the incidence and severity of toxicities, and reversibility of toxicities of subjects as a function of the treatments rendered.		3-6 months	Yes