XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
Oxaliplatin
+ Capecitabine
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Prevention Study
Summary
Study start date: November 17, 2017
Actual date on which the first participant was enrolled.Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. In the CLASSIC trial, capecitabine plus oxaliplatin for 6 months following D2 gastrectomy has been established as an effective postoperative adjuvant treatment for patients with operable stage II or III gastric cancer. However, due to adverse events, chemotherapy discontinuations occurred in 50 (10%) patients, primarily due to nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al. reported the results of the IDEA trial. For patients with lymph node-positive colon cancer (stage III), some may benefit from a shorter duration of chemotherapy post-surgery. An analysis of six clinical trials involving over 12,800 patients showed that 3 months of chemotherapy was nearly as effective as 6 months for patients with a lower recurrence risk, while also causing fewer side effects, particularly nerve damage. Based on the findings from the IDEA trial, we hypothesize that a 4-month regimen of capecitabine plus oxaliplatin may also benefit patients following D2 gastrectomy while reducing adverse events compared with the standard 6-month regimen.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1024 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Sun Yat-sen University Cancer Center
Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google MapsThe First Affiliated Hospital of Anhui Medical University
Hefei, ChinaThe First Affiliated Hospital of University of Science and Technology of China
Hefei, ChinaJiangsu Cancer Hospital
Nanjing, China