A Study to Estimate Overall Survival in Patients Receiving Best Supportive Care for Treatment-Resistant, Metastatic Colorectal Carcinoma

NCT ID: NCT03096899

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-08-22

Brief Summary

The primary objective of this study is to estimate overall survival in patients only receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal carcinoma. The primary efficacy outcome is overall survival, defined as the time from the date of the radiographic scan demonstrating disease progression post available treatments (time of origin, T0) to death from any cause.

Detailed Description

This is a retrospective chart review and prospective observational study. Patients will be considered for enrollment if they are receiving BSC and have already decided independently of this study not to pursue further therapeutic treatment of their cancer. Patients must have received at least two prior treatments for their disease, such as chemotherapy, targeted therapy or other regimens.

The study will consist of administration of informed consent, which will include permission to review medical records and record relevant medical information, agreement to be followed for survival, and evaluation of the appropriate inclusion/exclusion entry criteria.

Patients will not have any study-specific assessments performed as part of this study, and will be followed only for survival.

Approximately 80 patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC, will be entered in the study at no more than five sites in the United States

Conditions

Metastatic Colorectal Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Observational

Best Supportive Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients must meet all of the following criteria to be considered eligible to participate in the study:

1. Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic adenocarcinoma of the colon or rectum that is resistant to available treatment options, including at least two such options from available chemotherapy, targeted and other regimens.

2. Radiographically documented evidence of disease progression from the most recent therapy administered prior to the initiation of BSC.

3. Life expectancy of at least six weeks, in the Investigator's opinion, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC.

4. In the Investigator's opinion, a surgical candidate at the time of disease progression. Initiation of treatment with BSC only within two months.

5. Able to provide written informed consent (by patient or family member or health proxy).

Exclusion Criteria

Patients who, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC, meet any of the following criteria will be excluded from participating in the study:

1. Documentation of hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis, and/or a large volume of ascites.

2. Documentation of concurrent cancer of any other type (Note: patients with non-melanoma skin cancers are still considered eligible).

3. Documentation of positive test result for human immunodeficiency virus (HIV) or any hepatitis (other than Hepatitis A).

4. Considered by the Investigator to be unsuitable for participation in the study upon review of medical history, physical examination or clinical laboratory test results.-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Rogosin Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Smith, M.D., Ph.D.

Role: STUDY_DIRECTOR

The Rogosin Institute

Locations

Calvary Hospital

The Bronx, New York, United States

Countries

United States

Other Identifiers

RI-CR-002

Identifier Type: -

Identifier Source: org_study_id