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Comparison of Standard of Care or Treatment on Protocol

NCT ID: NCT01010334

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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INST 0813 Standard of Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Arm 1

Standard of Care Treatment

Group Type ACTIVE_COMPARATOR

standard of care

Intervention Type OTHER

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.

Arm 2

Treatment Arm of a separate protocol (physician discretion)

Group Type EXPERIMENTAL

standard of care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Standard of Care therapy (disease site based) VARIIOUS experimental therapies (based on protocol for which pt failed eligibility)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Verschraegen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-02680

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 0813

Identifier Type: -

Identifier Source: org_study_id