Comparison of Standard of Care or Treatment on Protocol - Full Text View

Purpose

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	Intervention
Stomach Cancer Esophageal Cancer Bladder Cancer Skin Cancer Lung Cancer Uterine Cancer Ovarian Cancer	Other: standard of care

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Esophageal Cancer Esophagus Disorders Lung Cancer Ovarian Cancer Skin Cancer Stomach Cancer Uterine Cancer

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	13
Study Start Date:	March 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Arms

Assigned Interventions

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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010334

Locations

United States, New Mexico
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

More Information

No publications provided

Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT01010334 History of Changes
Other Study ID Numbers:	INST 0813, NCI-2011-02680
Study First Received:	July 24, 2009
Last Updated:	February 18, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:

INST 0813
Standard of Care

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Skin Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Lung Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Skin Diseases

Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on June 18, 2013