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Spots Global Cancer Trial Database for Regorafenib in Metastatic Colorectal Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Regorafenib in Metastatic Colorectal Cancer

Official Title: Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study

Study ID: NCT02466009

Interventions

Regorafenib

Study Description

Brief Summary: The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

Detailed Description: Subjects will be asked to participate in the study because they are aged 70 or older and require treatment for colorectal cancer that has spread to other parts of the body and has not gotten better with other treatment. Subjects will undergo some initial tests to ensure that they meet all criteria necessary to participate in the study. Once the subject has completed initial testing and meets eligibility criteria, the subject will begin treatment with 120 mg of regorafenib (3 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks). After the first cycle, the doctor will discuss the possibility of increasing the dose to 160 mg (4 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks) based on the subjects health status. During the study, assessments will be performed to monitor the subjects tolerance and response to the treatment. Regorafenib will continue as long as the subject is tolerating the treatment and the subjects colorectal cancer is either responding to treatment or remains stable.

Eligibility

Minimum Age: 70 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic, Rochester, Minnesota, United States

University of Rochester, Rochester, New York, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Contact Details

Name: Aram Hezel, M.D.

Affiliation: University of Rochester

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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