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)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22356
• 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

University of North Carolina at Chapel Hill

Department of Epidemiology

Study timelines

Date when funding contract was signed

Actual: 02/02/2017

Study start date

Actual: 02/02/2017

Date of final study report

Planned: 31/05/2018

Sources of funding

Other

More details on funding

UNC Lineberger Comprehensive Cancer Center

Study protocol

Initial protocol

CSDR_submission_Lund

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Access to data for this study was approved and obtained via clinicalstudydatarequest.com (CSDR). Our proposal number on CSDR is 1660. https://www.clinicalstudydatarequest.com/