Study identification

EU PAS number

EUPAS22355

Study ID

22356

Official title and acronym

Assessing the generalizability of all-cause mortality from the MOSAIC trial to older adults diagnosed with stage II and III colon cancer in SEER-Medicare (Generalizability of colon cancer trial results)

DARWIN EU® study

No

Study countries

United States

Study description

In this study, we propose to apply generalizability weighting methods using data from older adults (age 65-75 years) enrolled in the MOSAIC randomized controlled trial (RCT) and SEER-Medicare observational cohort (a linkage of cancer registry and Medicare enrollment and claims data). Specifically, we aim to: (1) estimate the expected effects of adjuvant chemotherapy with oxaliplatin versus 5-fluorouracil (5-FU) alone in routine care populations of older adults (age 65-75 years) diagnosed with stage II and III colon cancer and (2) assess whether we can use the MOSAIC data to predict all-cause mortality in an observational SEER-Medicare cohort of older adults. We will conduct a cohort study using patient-level MOSAIC trial data and aggregated information from the SEER-Medicare database, providing the unique opportunity to pursue our aims. We will plan to present our research findings at scientific conferences and publish our results in a peer-reviewed journal.

Study status

Ongoing
Research institutions and networks

Institutions

Department of Epidemiology

Contact details

Jennifer Lund

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

UNC Lineberger Comprehensive Cancer Center
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable