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

Withdrawn before enrolling

Conditions studied: Metastatic Colorectal Carcinoma

In brief

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.

Key facts

Study ID

NCT03096899

Run by

The Rogosin Institute

People needed

0

Starts

2016-01-01

Expected to finish

2018-08-22

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria to be considered eligible to participate in the study:
• 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.
• Radiographically documented evidence of disease progression from the most recent therapy administered prior to the initiation of BSC.
• 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.
• In the Investigator's opinion, a surgical candidate at the time of disease progression. Initiation of treatment with BSC only within two months.
• Able to provide written informed consent (by patient or family member or health proxy).

You may not qualify if…

• 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:
• Documentation of hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis, and/or a large volume of ascites.
• Documentation of concurrent cancer of any other type (Note: patients with non-melanoma skin cancers are still considered eligible).
• Documentation of positive test result for human immunodeficiency virus (HIV) or any hepatitis (other than Hepatitis A).
• Considered by the Investigator to be unsuitable for participation in the study upon review of medical history, physical examination or clinical laboratory test results.-

Where it is running

• Calvary Hospital — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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