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

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.

Study Overview

• Status: Terminated
• Conditions: Stomach Cancer; Esophageal Cancer; Ovarian Cancer; Lung Cancer; Bladder Cancer; Skin Cancer; Uterine Cancer
• Intervention / Treatment: Other: standard of care

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of courses delivered (relative dose intensity for adjuvant studies)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	6 months
Response rate	6 months
Progression- or disease-free survival (for metastatic disease)	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

Collaborators and Investigators

• Sponsor: New Mexico Cancer Care Alliance
• Investigators: Principal Investigator: Claire Verschraegen, MD, University of New Mexico Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 24, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Standard of Care; INST 0813
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: INST 0813; NCI-2011-02680 (Registry Identifier: NCI CTRP)