XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

NCT03399110 | Completed Phase 3 DMC

• 1 other identifier: LOMAC
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 10

Brief Summary

Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer. Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower treatment-related toxicity.

Conditions

Gastric Cancer

Keywords

Adjuvant chemotherapy; Gastric Cancer; Non-inferiority; Oxaliplatin; Capecitabine

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease-free survival, defined as the time from randomization to the first occurrence of disease recurrence or death from any cause.

  3 years

Secondary Outcomes (2)

• Adverse Events

  6 months

• OS

  3 years

Study Arms (2)

XELOX for 4 months

EXPERIMENTAL

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 6 cycles (A minimum of 5 cycles was permitted only for patients who could not tolerate full-dose therapy due to unacceptable toxicity), 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 approximately 4 months.

Drug: Oxaliplatin; Drug: Capecitabine

XELOX for 6 months

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.

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Oxaliplatin DRUG

Oxaliplatin 130 mg/m2

Also known as: Eloxatin

XELOX for 4 months; XELOX for 6 months

Capecitabine DRUG

Capecitabine 1000 mg/m2

Also known as: Xeloda

XELOX for 4 months; XELOX for 6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years.
• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, staged as II, IIIA, or IIIB according to the American Joint Committee on Cancer classification system, eighth edition.
• Underwent R0 gastrectomy with D2 lymphadenectomy.
• No other concurrent malignancies.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• No contraindications to chemotherapy.

You may not qualify if:

• Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy.
• Patients with stage I, IIIC, or IV gastric cancer.
• Severe cardiac, pulmonary, neurologic, hepatic, or other major organ dysfunction.
• Known or suspected drug allergies.
• Pregnant or lactating women.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (10)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

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

Hefei, China

Location

Jiangsu Cancer Hospital

Nanjing, China

Location

Changhai Hospital

Shanghai, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Second Affiliated Hospital (Changzheng Hospital) of Naval Medical University

Shanghai, China

Location

Shanghai East Hospital

Shanghai, China

Location

Liaoning Cancer Hospital

Shenyang, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dazhi Xu, PHD, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: January 14, 2018
• Primary Completion: August 15, 2026
• Study Completion: August 15, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication and ending 5 years after publication
• Access Criteria: Requests should include a scientifically sound research proposal, analysis plan, and information regarding the qualifications of the requesting investigators. Requests will be reviewed by the study investigators. Data will be shared only after approval of the proposal and completion of any required data-use agreement and institutional or ethical approvals.

Locations

CN (10)