Metronomic Capecitabine in Stage III Gastric Cancer
Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial
1 other identifier
interventional
722
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedStudy Start
First participant enrolled
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 10, 2029
July 8, 2024
July 1, 2024
5 years
March 10, 2024
July 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
DFS
3-year
Secondary Outcomes (2)
Overall survival
3-year
Side effects
1-year
Study Arms (2)
Metronomic capecitabine
EXPERIMENTALLow-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,
Standard therapy group
ACTIVE COMPARATORObservation after completion of standard adjuvant chemotherapy,
Interventions
500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group
Eligibility Criteria
You may qualify if:
- Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
- R0 gastrectomy with D2 lymphadenectomy
- ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
- 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).
You may not qualify if:
- History of chemotherapy, radiotherapy, immunotherapy or target therapy
- Multiple primary tumors
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
- Unavailable for R0 resection and D2 lymph node dissection.
- Patients with stage IV gastric cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 15, 2024
Study Start
March 10, 2024
Primary Completion (Estimated)
March 10, 2029
Study Completion (Estimated)
March 10, 2029
Last Updated
July 8, 2024
Record last verified: 2024-07