Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer

Description

[Overview] Investigators will obtain voluntary consent for participation in this study from patients with high-risk stage II or stage III colon cancer who require or are planning to receive adjuvant chemotherapy after curative resection. Patients who provided written consent for using their personal information and who satisfy inclusion/exclusion criteria will be given a study enrollment number. Among the predefined study-relevant data, available data on these patients will be collected in the case report forms (CRF) until the study is completed.

[Follow-up observation schedule and the scope of data collection] Since this study is an observational study, data collection in the CRF will be restricted to the data created only from usual treatment practices and there will be no separate test or additional drug administration for the study. However, subjects will be asked to complete questionnaire to evaluate their quality of life at the following time points: baseline, Month 3 (13 weeks 2 weeks), Month 6 (26 weeks 2 weeks), Month 12 (52 weeks 4 weeks), Month 24 (104 weeks 8 weeks), Month 36 (156 weeks 8 weeks). For subjects who drop out from the study or in case of disease event (relapse, metastasis or new primary malignant tumor), the questionnaire will be conducted at the time of drop-out or disease event. Survival of all subjects (including those who drop out from the study or whose disease event is confirmed) will be checked every 6 months after adjuvant chemotherapy started. Among the data created from the subjects on their visits for treatment, the following data will be collected for the purpose of this study.

• Demographics of the subjects.
• Colon cancer information (diagnosis information, risk factors, surgery information).
• Whether or not neoadjuvant chemotherapy was conducted.
• Underlying disease.
• Adjuvant chemotherapy information.
• Other concomitant medication (drugs administered for prevention and treatment of OXLIPN, drugs administered for treatment of Grade 3-4 adverse drug reactions/serious adverse drug reactions related to the chemotherapy).
• Vital signs, height, and weight.
• Performance Status evaluation (ECOG PS).
• Geriatric Assessment (KG-7): for subjects 65 years old.
• Quality of Life assessment (FACT-C, FACT/GOG-NTX-12).
• Laboratory test results.
• Tumor Marker (CEA, CA 19-9) test results.
• Molecular genetic test results (MSI [microsatellite instability] and/or MMR [DNA mismatch repair gene], immunohistochemistry test for protein, KRAS, NRAS, BRAF etc.).
• Colonoscopy/CT results.
• Disease event (relapse, metastasis or new primary malignant tumor).
• Survival of subjects.
• Oxaliplatin-induced Peripheral Neuropathy (OXLIPN): Only when oxaliplatin is administered.
• Grade 3-4 adverse drug reactions related to chemotherapy (based on CTCAE v.5.0).
• Serious adverse drug reactions.

Details