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Comparison of Standard of Care or Treatment on Protocol

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ClinicalTrials.gov Identifier: NCT01010334
Recruitment Status : Terminated (PI deparature and very low (<2%) accrual rate.(No results required))
First Posted : November 10, 2009
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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
Stomach Cancer Esophageal Cancer Bladder Cancer Skin Cancer Lung Cancer Uterine Cancer Ovarian Cancer Other: standard of care Not Applicable

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 : Interventional  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011


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)




Primary Outcome Measures :
  1. Number of courses delivered (relative dose intensity for adjuvant studies) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 6 months ]
  2. Progression- or disease-free survival (for metastatic disease) [ Time Frame: 6 months ]
  3. Overall survival [ Time Frame: 6 months ]
  4. Describe all adverse events of grade > 3 and Serious Adverse Events [ Time Frame: 6 months ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01010334     History of Changes
Other Study ID Numbers: INST 0813
NCI-2011-02680 ( Registry Identifier: NCI CTRP )
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013

Keywords provided by New Mexico Cancer Care Alliance:
INST 0813
Standard of Care

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Esophageal Neoplasms
Skin Neoplasms
Stomach Neoplasms
Uterine Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Skin Diseases
Stomach Diseases
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female