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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    1032
  • sponsor
    Fudan University
Updated on 22 January 2021
gastrectomy
oxaliplatin
capecitabine
cancer chemotherapy
adenocarcinoma
adjuvant chemotherapy
immunostimulants
xelox regimen

Summary

Our study aims to compare the efficacy and safety of capecitabine and oxaliplatin for 4 months versus 6 months as adjuvant chemotherapy after D2 Gastrectomy in patients with gastric cancer.

Hypothesis: For gastric patients after D2 Gastrectomy, capecitabine and oxaliplatin for 4 months show noninferiority to capecitabine and oxaliplatin for 6 months in disease-free survival (DFS) and safety.

Description

Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. Capecitabine plus oxaliplatin for 6 months after D2 gastrectomy is considered as effective postoperative adjuvant treatment for patients with operable stage II or III gastric cancer in the CLASSIC trail. However, because of adverse events discontinuations in the chemotherapy group occurred in 50 (10%) patients, mainly as a result of nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al reported the result of IDEA trail. For lymph node-positive colon cancer (stage III), some patients may need only half of the long-standing standard course of chemotherapy after surgery. In an analysis of 6 clinical trials with over 12,800 patients, 3 months of chemotherapy was nearly as effective as 6 months in patients with relatively lower recurrence risk and caused fewer side effects, particularly nerve damage. Based on IDEA trail, we postulate that the chemotherapy of capecitabine plus oxaliplatin for 4 months may also benefit patients after D2 gastrectomy and decrease adverse events compared with 6 months.

Details
Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Capecitabine, Oxaliplatin
Clinical Study IdentifierNCT03399110
SponsorFudan University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The lower age limit of research subjects 18 years old and upper age limit of 75 years old
Be proven to be primary adenocarcinoma of gastric cancer and staged II, IIIA or IIIB by pathological evidence
R0 resection and D2 Gastrectomy
Without any other malignancies
PS (ECOG) of 0 or 1 and expected to survive more than 6 months
No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram WBC4.0 x 109 /L, NEU1.5 x 109 /L,PLT100 x 109 /L and HGB90g/L)

Exclusion Criteria

Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
Patients with stage I, IIIC and IV
Unavailable for R0 resection and D2 Gastrectomy
Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection
With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension
Any Known or suspected history of drug allergy test
The researchers believe the patient is not able to complete the entire course of the experiment
Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy
Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases
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