Comparison of Standard of Care or Treatment on Protocol

This study has been terminated.

(PI deparature and very low (<2%) accrual rate.)

Sponsor:

Information provided by (Responsible Party):

New Mexico Cancer Care Alliance

ClinicalTrials.gov Identifier:

NCT01010334

First received: July 24, 2009

Last updated: February 18, 2013

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 24, 2009

Last Updated Date

February 18, 2013

Start Date ^ICMJE

March 2009

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of courses delivered (relative dose intensity for adjuvant studies) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Outcome between patients treated on study vs. non-eligible patients using approved drugs [ Time Frame: 6 monthsd ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01010334 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Standard of Care or Treatment on Protocol

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01010334

Other Study ID Numbers ^ICMJE

INST 0813, NCI-2011-02680

Has Data Monitoring Committee

Responsible Party

New Mexico Cancer Care Alliance

Study Sponsor ^ICMJE

New Mexico Cancer Care Alliance

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Claire Verschraegen, MD

University of New Mexico Cancer Center

Information Provided By

New Mexico Cancer Care Alliance

Verification Date

October 2012

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

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