Status:
ACTIVE_NOT_RECRUITING
XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)
Lead Sponsor:
Fudan University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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. Hypothesi...
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 ...
Eligibility Criteria
Inclusion
- 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 （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L).
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT03399110
Start Date
December 1 2017
End Date
August 1 2026
Last Update
March 12 2024
Active Locations (9)
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1
Anqing Municipal Hospital
Anqing, Anhui, China
2
Anhui Provincial Hospital
Hefei, Anhui, China
3
First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
4
Yuebei People's Hospital
Guangzhou, Guangdong, China