Comparison of Standard of Care or Treatment on Protocol

Not Applicable

Terminated

• Conditions: Ovarian Cancer; Stomach Cancer; Esophageal Cancer; Uterine Cancer; Skin Cancer; Lung Cancer; Bladder Cancer
• Interventions: Other: standard of care

• Registration Number: NCT01010334
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-13
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 2	standard of care	Treatment Arm of a separate protocol (physician discretion)
Arm 1	standard of care	Standard of Care Treatment

Primary Outcome Measures

Name	Time	Method
Number of courses delivered (relative dose intensity for adjuvant studies)	6 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	6 months
Progression- or disease-free survival (for metastatic disease)	6 months
Response rate	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

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States