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Comparison of Standard of Care or Treatment on Protocol

This study has been terminated.
(PI deparature and very low (<2%) accrual rate.(No results required))
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01010334
First received: July 24, 2009
Last updated: August 13, 2013
Last verified: August 2013

July 24, 2009
August 13, 2013
March 2009
July 2011   (final data collection date for primary outcome measure)
Number of courses delivered (relative dose intensity for adjuvant studies) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Outcome between patients treated on study vs. non-eligible patients using approved drugs [ Time Frame: 6 monthsd ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01010334 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression- or disease-free survival (for metastatic disease) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Describe all adverse events of grade > 3 and Serious Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparison of Standard of Care or Treatment on Protocol
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
  • Stomach Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Skin Cancer
  • Lung Cancer
  • Uterine Cancer
  • Ovarian Cancer
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)
  • Active Comparator: Arm 1
    Standard of Care Treatment
    Intervention: Other: standard of care
  • Experimental: Arm 2
    Treatment Arm of a separate protocol (physician discretion)
    Intervention: Other: standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01010334
INST 0813, NCI-2011-02680
No
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Claire Verschraegen, MD University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP