Lead Investigator: Jennifer Lund, University of North Carolina at Chapel Hill
Title of Proposal Research: Improving Colon Cancer Therapy Decisions by Extending Trial Representation
Vivli Data Request: 7848
Funding Source: This work has been funded by the Patient-Centered Outcomes Research Institute (PCORI). This is a non-governmental agency – our funding is through a contract (ME-2017C3-9337).
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Colon cancer is the third most common cancer diagnosed among men and women in the United States. Treatment for colon cancer often includes surgery followed by treatment with chemotherapy. When choosing a chemotherapy, doctors and patients generally discuss the trade-offs for the treatment, including its benefits – like reducing the chance that the cancer will come back – and its harms – like increasing the chance of having an adverse event that requires you to unexpectedly go to the hospital.
Information about the benefits and harms of chemotherapy are carefully studied in clinical trials. However, getting involved in a clinical trial can be difficult and as a result, cancer patients that participate are often different from those who do not. Studies have shown that less than 5% of all cancer patients enroll onto cancer treatment trials, and specific groups of patients, including adults over the age of 70, are less likely to participate at all. Because of this, it can be difficult for doctors to tell their older patients what the benefits and harms of a given treatment are, as people like them were not included in large enough numbers in the clinical trial.
In this study, our goal is to come-up with better information about the benefits and harms of treatment that can be used by doctors and a wide variety of colon cancer patients, including older patients, to make decisions about what chemotherapy to choose. We will compare the benefits and harms of two different chemotherapy treatments for colon cancer and look to see whether a shorter period of treatment (like 3 months) can provide the same benefits as a longer period of treatment (like 6 months), but with less harm. For this study, we will use information from colon cancer patients that participated in a large clinical trial of chemotherapy and information from colon cancer patients who were not treated in a clinical trial, but were instead treated by a doctor in regular clinic setting. The results of this study have the potential to help doctors and patients choose the chemotherapy with the most benefit and least harm, and in turn, improve patients overall health and quality of life.
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Data Contributor: Sanofi
Study ID: NCT00275210
Sponsor ID: EFC3313
The Ontada/US Oncology iKnowMed Electronic Health Record (EHR) database is an oncology-specific, integrated, web-based EHR system capturing outpatient encounter data for patients treated at >400 community oncology practices. Overall, iKnowMed captures about 10% of newly-diagnosed cancer patients in the US (≈750,000) annually, including over 1,000 physicians from community-based oncology practices from 2008-2020. In the proposed study, we will statistically transport the treatment effects observed within the MOSAIC trial to a target population of patients with treatment data captured within the iKnowMed database. Specifically, we will use de-identified, patient-level data on all stage II/III colon cancer patients treated within the US Oncology network from 2008-20. This data source is ideal for this study because they contain accurate and detailed information from clinical practice settings regarding patient demographics, clinical variables, functional assessments (ECOG), tumor characteristics, and therapy delivery (e.g., dose, timing of administration, regimen). The iKnowMed data have been used to address an array of cancer-related research questions.
Data Contributor: I WILL BRING MY OWN
Sponsor ID: Ontada/US Oncology iKnowMed data