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Comparison of Standard of Care or Treatment on Protocol

Sponsor
New Mexico Cancer Care Alliance (Other)
Overall Status
Terminated
CT.gov ID
NCT01010334
Collaborator
(none)
13
Enrollment
1
Location
2
Arms
28
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: standard of care
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
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
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1

Standard of Care Treatment

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.
Other Names:
  • Standard of Care therapy (disease site based)
  • VARIIOUS experimental therapies (based on protocol for which pt failed eligibility)

    		•
    Experimental: Arm 2

    Treatment Arm of a separate protocol (physician discretion)

    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.
    Other Names:
  • Standard of Care therapy (disease site based)
  • VARIIOUS experimental therapies (based on protocol for which pt failed eligibility)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of courses delivered (relative dose intensity for adjuvant studies) [6 months]

    Secondary Outcome Measures

    1. Response rate [6 months]

    2. Progression- or disease-free survival (for metastatic disease) [6 months]

    3. Overall survival [6 months]

    4. Describe all adverse events of grade > 3 and Serious Adverse Events [6 months]

    5. Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Albuquerque New Mexico United States 87106

    Sponsors and Collaborators

    • New Mexico Cancer Care Alliance

    Investigators

    • Principal Investigator: Claire Verschraegen, MD, University of New Mexico Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    New Mexico Cancer Care Alliance
    ClinicalTrials.gov Identifier:
    NCT01010334
    Other Study ID Numbers:
    • INST 0813
    • NCI-2011-02680
    First Posted:
    Nov 10, 2009
    Last Update Posted:
    Aug 14, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by New Mexico Cancer Care Alliance
    INST 0813
    Standard of Care
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Uterine Neoplasms

    Study Results

    No Results Posted as of Aug 14, 2013