Metronomic Capecitabine in Stage III Gastric Cancer

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Gastric Cancer

Treatments: Other: Observation; Drug: Metronomic capecitabine group

Study type: Interventional

Funder types: Other

Identifiers

NCT06313567

Meca-GC

Details and patient eligibility

About

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.

Enrollment: 722 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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722 participants in 2 patient groups

Metronomic capecitabine

Experimental group

Description:

Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,

Treatment:

Drug: Metronomic capecitabine group

Standard therapy group

Active Comparator group

Description:

Observation after completion of standard adjuvant chemotherapy,

Treatment:

Other: Observation