Study Stopped
PI deparature and very low (\<2%) accrual rate.(No results required)
Comparison of Standard of Care or Treatment on Protocol
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
2 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedAugust 14, 2013
August 1, 2013
2.3 years
July 24, 2009
August 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of courses delivered (relative dose intensity for adjuvant studies)
6 months
Secondary Outcomes (5)
Response rate
6 months
Progression- or disease-free survival (for metastatic disease)
6 months
Overall survival
6 months
Describe all adverse events of grade > 3 and Serious Adverse Events
6 months
Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment
6 months
Study Arms (2)
Arm 1
ACTIVE COMPARATORStandard of Care Treatment
Arm 2
EXPERIMENTALTreatment Arm of a separate protocol (physician discretion)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients must have a cancer requiring chemotherapy or radiotherapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire Verschraegen, MD
University of New Mexico Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2009
First Posted
November 10, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 14, 2013
Record last verified: 2013-08