Metronomic Capecitabine in Stage III Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313567
• Other study ID #: Meca-GC
• Status: Recruiting
• Phase: Phase 3
• Start date: March 10, 2024
• Est. completion date: March 10, 2029

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: Jing Guo, MD
• Phone: 021-64175590
• Email: gjsysu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 722
• Est. completion date: March 10, 2029
• Est. primary completion date: March 10, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Metronomic capecitabine
650 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group

Other:
• Observation
observation

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	DFS	3-year
Secondary	Overall survival	OS	3-year
Secondary	Side effects	Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder	1-year