Suspended

XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Oxaliplatin

+ Capecitabine

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 80 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: November 2017
See protocol details

Summary

Principal SponsorFudan University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleXELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
Principal SponsorFudan University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1024 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

6 inclusion criteria required to participate
Age between 18 and 80 years.

Histologically confirmed primary adenocarcinoma of the stomach, staged as II, IIIA, or IIIB according to pathological findings.

R0 resection and D2 gastrectomy performed.

No other concurrent malignancies.

Show More Criteria

5 exclusion criteria prevent from participating
Pregnant or lactating women.

Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy.

Patients with stage I, IIIC, or IV gastric cancer.

Presence of severe organ diseases, including heart, lung, brain, liver, or other vital organ dysfunction.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 5 to 6 cycles, each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 5 to 6 months or until disease progression.

Group II

Active Comparator
Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months or until disease progression.

Study 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

Suspended

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps
Suspended

The First Affiliated Hospital of Anhui Medical University

Hefei, China
Suspended

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China
Suspended

Jiangsu Cancer Hospital

Nanjing, China
Suspended9 Study Centers