Phase II Study Comparing 2-Hour Versus 6-Hour Oxaliplatin Infusions to Reduce Nerve Damage in Patients With Gastrointestinal Cancers

What this Trial Is About

Researchers are studying how the duration of oxaliplatin infusion affects nerve damage in patients with gastrointestinal cancers. This phase II trial compares giving oxaliplatin over 2 hours versus 6 hours to see if a longer infusion can reduce or delay nerve damage, which may allow patients to stay on standard chemotherapy doses longer without delays. The European Organization for Research and Treatment of Cancers patient-reported neuropathy scale CIPN-20 is used to measure nerve damage severity. Participants are randomly assigned to one of two groups one receives oxaliplatin and leucovorin intravenously over 2 hours along with fluorouracil given in two doses a quick low dose and a continuous higher dose on day 1 the other receives oxaliplatin over 6 hours with leucovorin and fluorouracil as in the first group. Treatments are repeated every 14 days unless disease progresses or side effects are unacceptable. After treatment, patients are followed up at 1, 3, 6, 12, and 18 months. Throughout the study, patients undergo evaluations including measurements of nerve damage using the CIPN-20 scale, pharmacokinetic tests to assess drug concentration and clearance, tumor size monitoring, and records of therapy duration, dose adjustments, and treatment delays. These assessments help researchers understand how infusion time affects nerve damage severity and overall treatment delivery. The total participation duration includes the treatment period and up to 18 months of follow-up.

2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers