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

NCT03096899 | Withdrawn FDA Drug

• 1 other identifier: RI-CR-002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Death from any cause.

  From the date of prior radiographically documented disease progression associated with the most recent therapy administered prior to the initiation of BSC to the date of death, assessed up to 10 years

Interventions

Observational OTHER

Best Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study patient population is composed of patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC.

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.-

Sponsors & Collaborators

• The Rogosin Institute: lead

Study Sites (1)

Calvary Hospital

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Barry Smith, M.D., Ph.D.

  The Rogosin Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 30, 2017
• Study Start: January 1, 2016
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)