Comparison of Standard of Care or Treatment on Protocol

Lung Cancer Clinical Trial

Official title:

Randomized Study of Patients (Patient Choice) Who Are Not Eligible for Variations of Standard of Care Protocols When Treated Either on Best Standard of Care Pathways or Per a Protocol Arm That They Failed to Enroll to

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01010334
• Other study ID #: INST 0813
• Secondary ID: NCI-2011-02680
• Status: Terminated
• Phase: N/A
• First received: July 24, 2009
• Last updated: August 13, 2013
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.

Description:

All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have a cancer requiring chemotherapy or radiotherapy

Exclusion Criteria:

• Inability to comply with study and/or follow-up procedures

• Any contraindication per the FDA notice to the selected drugs

• Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bladder Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Lung Cancer
• Ovarian Cancer
• Skin Cancer
• Stomach Cancer
• Stomach Neoplasms
• Uterine Cancer
• Uterine Neoplasms

Intervention

Other:
• standard of care
All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy, OR to one of the arms of the protocol they failed to enroll in, as determined by the treating physician.

Locations

Country	Name	City	State
United States	University of New Mexico	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	Number of courses delivered (relative dose intensity for adjuvant studies)		6 months	No
Secondary	Response rate		6 months	No
Secondary	Progression- or disease-free survival (for metastatic disease)		6 months	No
Secondary	Overall survival		6 months	No
Secondary	Describe all adverse events of grade > 3 and Serious Adverse Events		6 months	Yes
Secondary	Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment		6 months	No