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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03399110
• Other study ID #: GCGC005
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 1, 2017
• Est. completion date: August 1, 2026

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1032
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
oxaliplatin 130 mg/m2
• Capecitabine
Capecitabine 1000mg/m2

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing	Anhui
China	Yuebei People's Hospital	Guangzhou	Guangdong
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Lishui Hospital of Zhejiang University	Lishui	Zhejiang
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	Disease-free survival	3-year
Secondary	Adverse Events	Adverse Events of Chemotherapy	1-year
Secondary	OS	Overall survival	3-year