Metronomic Capecitabine in Stage III Gastric Cancer

Phase 3

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Metronomic capecitabine group; Other: Observation

• Registration Number: NCT06313567
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-10
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2029-03-10
• Study Completion: 2029-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 722

Inclusion Criteria

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Exclusion Criteria

1. History of chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for R0 resection and D2 lymph node dissection.
5. Patients with stage IV gastric cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronomic capecitabine	Metronomic capecitabine group	Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,
Standard therapy group	Observation	Observation after completion of standard adjuvant chemotherapy,

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3-year	DFS

Secondary Outcome Measures

Name	Time	Method
Overall survival	3-year	OS
Side effects	1-year	Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China