Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
722 participants
INTERVENTIONAL
2024-03-10
2029-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metronomic capecitabine
Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,
Metronomic capecitabine group
500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group
Standard therapy group
Observation after completion of standard adjuvant chemotherapy,
Observation
observation
Interventions
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Metronomic capecitabine group
500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group
Observation
observation
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Dazhi Xu
Professor
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Meca-GC
Identifier Type: -
Identifier Source: org_study_id
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