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
  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:


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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 13, 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:
Ovarian Neoplasms
Esophageal Neoplasms
Urinary Bladder Neoplasms
Stomach Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Stomach Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on September 18, 2014