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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


N/A
18 Years
N/A
Not Enrolling
Both
Stomach Cancer, Esophageal Cancer, Bladder Cancer, Skin Cancer, Lung Cancer, Uterine Cancer, Ovarian Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of courses delivered (relative dose intensity for adjuvant studies)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Claire Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

INST 0813

NCT ID:

NCT01010334

Start Date:

March 2009

Completion Date:

July 2011

Related Keywords:

  • Stomach Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Skin Cancer
  • Lung Cancer
  • Uterine Cancer
  • Ovarian Cancer
  • INST 0813
  • Standard of Care
  • Urinary Bladder Neoplasms
  • Skin Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Uterine Neoplasms

Name

Location
University of New Mexico Albuquerque, New Mexico  87131