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

NCT ID: NCT03399110

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1032 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2026-08-01

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

XELOX for 4 months

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery (five 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 4 months or progress of disease

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

oxaliplatin 130 mg/m2

Capecitabine

Intervention Type: DRUG

Capecitabine 1000mg/m2

XELOX for 6 months

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery(eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

oxaliplatin 130 mg/m2

Capecitabine

Intervention Type: DRUG

Capecitabine 1000mg/m2

Interventions

Oxaliplatin

oxaliplatin 130 mg/m2

Intervention Type: DRUG

Capecitabine

Capecitabine 1000mg/m2

Intervention Type: DRUG

Other Intervention Names

Eloxatin; Xeloda

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dazhi Xu, PHD, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Anqing Municipal Hospital

Anqing, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Yuebei People's Hospital

Guangzhou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Lishui Hospital of Zhejiang University

Lishui, Zhejiang, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Countries

China

Other Identifiers

GCGC005

Identifier Type: -

Identifier Source: org_study_id