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Trial Title:
Metronomic Capecitabine in Stage III Gastric Cancer
NCT ID:
NCT06313567
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Conditions: Keywords:
Gastric Cancer
Metronomic capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Metronomic capecitabine group
Description:
500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group
Arm group label:
Metronomic capecitabine
Intervention type:
Other
Intervention name:
Observation
Description:
observation
Arm group label:
Standard therapy group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Dazhi Xu, MD,PHD
Phone:
021-64175590
Email:
xudzh@shca.org.cn
Start date:
March 10, 2024
Completion date:
March 10, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313567
