{"entity":{"id":"nct04137107","kind":"trial","name":"Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT04137107 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 220 participants, started 2020-06-17 and due to reach its primary completion in 2026-02-28. Interventions recorded: Oxaliplatin; Duloxetine Hydrochloride; Duloxetine; Quality-of-Life Assessment; Questionnaire Administration; Placebo. Conditions listed: Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8. Primary outcome: Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II); Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III); Chronic neuropathic pain response (Phase III). Colorectal eligibility wording from the registry: \"* Stage II-III colorectal cancer patients scheduled to receive oxaliplatin 510 mg/m\\^2 (cumulative dose) over 12 weeks as a component of adjuvant leucovorin calcium (calcium folinate), 5-fluorouracil and oxaliplatin (FOLFOX) treatment, in which patients are scheduled to receive oxaliplatin 85 mg/m\\^\". Sites: Guam, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04137107","url":"https://clinicaltrials.gov/study/NCT04137107"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04137107","phase":"2/3","setting":"Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study","sponsor":"Alliance for Clinical Trials in Oncology","enrolled":220,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04137107/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"}],"company":[{"id":"alliance-oncology","kind":"company","name":"Alliance for Clinical Trials in Oncology","route":"/companies/alliance-oncology/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}