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.
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
Allocation
RANDOMIZED
Masking
NONE
Enrollment
13
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.
University of New Mexico
Albuquerque, New Mexico, United States
Number of courses delivered (relative dose intensity for adjuvant studies)
Time frame: 6 months
Response rate
Time frame: 6 months
Progression- or disease-free survival (for metastatic disease)
Time frame: 6 months
Overall survival
Time frame: 6 months
Describe all adverse events of grade > 3 and Serious Adverse Events
Time frame: 6 months
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
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