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Adjuvant chemotherapy of docetaxel plus capecitabine versus oxalipatin plus capecitabine for gastric cancer after D2 gastrectomy: an open-label, phase III randomised controlled trial

Adjuvant chemotherapy of docetaxel plus capecitabine versus oxalipatin plus capecitabine for gastric cancer after D2 gastrectomy: an open-label, phase III randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034770
Enrollment
Unknown
Registered
2020-07-18
Start date
2020-07-31
Completion date
Unknown
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

experimental group:docetaxel plus capecitabine
control group:oxalipatin plus capecitabine

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Written (signed) informed consent.; 2. Without liver, peritoneal, retroperitoneal lymph node and other distant metastasis; 3. Pathological diagnosed gastric adenocarcinoma, recieving gastrectomy with D2 lymph node dissection, R0 resetion; 4. ECGO 0-1; 5. Female/male, 18-75year; 6. Expected survival > 3 months; 7. Laboratory detection in 7 days before inclusion should meet the following criteria: a. Adequate hematological function: Leukocyte >= 4.0 *10^9/L,Neutrophil count >= 1.5 * 10^9/L, Platelets >= 100 * 10^9/L and Hemoglobin >= 90g/L; b. Adequate liver function: Total bilirubin = 60 ml/min. d. Adequate coagulation function: INR/PT <= 1.5 x ULN, aPTT <= 1.5 * ULN. 8. Good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer,cervical or breast carcinoma in situ; 2. Intolerance of the oral drugs; 3. Patients with the history of chemotherapy, radiotherapy and immunotherapy; 4. Allergic to the investigatory drugs; 5. Female patients should not be pregnant or breast feeding; 6. Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance, or affect subjects' signing of informed consent (ICF), or ineligibility to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
disease free suvival;

Secondary

MeasureTime frame
overall survival;aderse event;

Countries

China

Contacts

Public ContactYuanfang Li

Sun Yat-Sen University Cancer Center

liyuanf@sysucc.org.cn+86 1372804220

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026