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



Status:Withdrawn
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:January 2016
End Date:August 22, 2018

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

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.

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

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.-
We found this trial at
1
site
Bronx, New York 10461
Phone: 718-518-2192
?
mi
from
Bronx, NY
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