NCT03096899

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: The Rogosin Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Observational	Best Supportive Care

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-08-22
• Completion: 2018-08-22
• First posted: 2017-03-30
• Last updated: 2018-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study