Clinical trial NCT03399110: XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)
Official title: XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric cancer,Adjuvant chemtherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 1032
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: DFS
timeFrame: 3-year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1-year
measure: OS
timeFrame: 3-year
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Wuhu
country: China
facility: First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Guangzhou
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Lishui
country: China
facility: Lishui Hospital of Zhejiang University
state: Zhejiang
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Fudan University
name: Dazhi Xu, PHD, MD
role: PRINCIPAL_INVESTIGATOR
References: