For many decades, rectal cancer has been managed using multimodal therapy, including surgery, radiation therapy, and chemotherapy. Advances within each field have challenged the traditional techniques and sequences of care to improve oncologic outcomes and allow for increased rates of rectal preservation. This, combined with the increased awareness of patient-reported outcomes and the long-term sequelae of treatment, has generated a wide array of research interests in rectal cancer treatment. A core outcome set (COS) for clinical trials in rectal cancer would help standardize outcome selection and reporting and facilitate the synthesis of data to best help inform treatment decisions.
Currently, a rectal cancer-specific COS does not exist. The CORMAC study developed a COS for trials of chemoradiotherapy for anal cancer (Fish et al. Lancet Gastroenterol Hepatol. 2018) and other investigator groups have developed COS for colorectal cancer research almost 10 years ago (McNair et al. PLoS Med. 2016; Zerillo et al. JAMA Oncol. 2017). Given the nuances and specificities of rectal cancer, none of these COS would be appropriate nor sufficient for the guidance of modern rectal cancer research, particularly in the era of nonoperative management. The purpose of this research project is to develop a COS to be used in research in the management of rectal cancer.
Richard Garfinkle, MD, McGill University
Dean Fergusson, PhD, Ottawa Hospital Research Institute
Marylise Boutros, MD, Cleveland Clinic Florida
Disease Category: Cancer
Disease Name: Rectal cancer
Age Range: 18 - 90
Sex: Either
Nature of Intervention: Chemotherapy , Drug, Immunotherapy, Radiotherapy, Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
- Systematic review
This core outcome set (COS) initiative will be a mixed-methods project designed in accordance with the COMET Handbook. A multidisciplinary study advisory group, composed of rectal cancer providers and methodologists, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter 2.0. A focus group including rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals (from different disciplines) will be invited to participate in a Delphi process to develop the final COS.