Comparison of Standard of Care or Treatment on Protocol

New Mexico Cancer Care Alliance

Status: Terminated

Conditions: Uterine Cancer; Bladder Cancer; Esophageal Cancer; Skin Cancer; Lung Cancer; Ovarian Cancer; Stomach Cancer

Treatments: Other: standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT01010334

NCI-2011-02680 (Registry Identifier)

INST 0813

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Standard of Care Treatment

Treatment:

Other: standard of care

Arm 2

Experimental group

Description:

Treatment Arm of a separate protocol (physician discretion)

Treatment:

Other: standard of care