Overview

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

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Sun Yat-sen University
Treatments:
Capecitabine
Oxaliplatin
Criteria
Inclusion Criteria:

1. The lower age limit of research subjects 18 years old and upper age limit of 75 years
old.

2. Be proven to be primary adenocarcinoma of gastric cancer and staged II, IIIA or IIIB
by pathological evidence

3. R0 resection and D2 Gastrectomy

4. Without any other malignancies

5. PS (ECOG) of 0 or 1 and expected to survive more than 6 months

6. No contraindications to chemotherapy, including normal peripheral blood routine,
liver, and kidney function and electrocardiogram (WBC≥4.0 x 109 /L, NEU≥1.5 x 109
/L,PLT≥100 x 109 /L and HGB≥90g/L).

Exclusion Criteria:

1. Female in pregnancy or lactation, or refuse to receive Contraception measures during
chemotherapy.

2. Patients with stage I, IIIC and IV.

3. Unavailable for R0 resection and D2 Gastrectomy.

4. Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic
infection.

5. With severe heart disease, including congestive heart failure, uncontrolled
arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and
resistant hypertension.

6. Any Known or suspected history of drug allergy test.

7. The researchers believe the patient is not able to complete the entire course of the
experiment.

8. Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy,
biological therapy, radiation therapy, or Immunosuppressive therapy.

9. Patients conform to any of the following: post-organ transplant, necessary for
long-term immunosuppressive or suffering with autoimmune diseases.