Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059805) titled 'Patient-Reported Outcomes in Patients with Metastatic Colorectal Cancer Treated with Fruquintinib: A Prospective Observational Study' on March 1.
Study Type:
Observational
Primary Sponsor:
Institute - Aichi Cancer Network
Condition:
Condition - Metastatic colorectal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To collect and analyze patient-reported outcomes (PROs) during fruquintinib treatment in patients with colorectal cancer, thereby elucidating adverse events and impacts on quality of life from the patient's perspective. This will support individualized treatment selection and dose adjustment, as well as the development of patient-centered supportive care strategies.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Histologically confirmed adenocarcinoma originating from the colon or rectum.
2.Unresectable Stage IV or recurrent colorectal cancer.
3.Age 18 years or older at the time of informed consent.
4.ECOG performance status of 0-2.
5.Planned to receive treatment with fruquintinib.
6.Able to complete PRO questionnaires.
Key exclusion criteria - 1. Deemed unsuitable for participation in the study at the discretion of the treating physician.
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 18 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2030 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068384
Disclaimer: Curated by HT Syndication.
