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A phase II study for systemic chemotherapy with docetaxel, oxaliplatin and xeloda followed by surgery in advanced gastric cancer

A phase II study for systemic chemotherapy with docetaxel, oxaliplatin and xeloda followed by surgery in advanced gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022226
Enrollment
Unknown
Registered
2019-03-30
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-04-01

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

Conditions

gastric carcinoma

Interventions

single arm:preoperative chemotherapy (Docetaxel, Oxaliplatin and Xeloda) +operation+postoperative chemotherapy

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, male or female. 2. Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, not signet -ring cell carcinoma. 3. ECOG(Eastern Cooperative Oncology Group ) 0-1. 4. T 3-4. 5. CT showed swelling lymph nodes, not bulky lymph node or N3(paraaortic). 6. No evidence of distant metastasis by CT; gastric cancer were able to resectable lesions. 7. Esophageal invasion greater than 3cm by endoscopy or X-ray; Not invade pancreatic head. 8. No peritoneal metastasis and CY0 by laparoscopy. 9. No prior chemotherapy or radiotherapy in 5 years. 10. Sufficient oral intake. 11. Available Organ function: Neutrophils=1.5x10^9/L; Hemoglobin >8g/L; Blood platelet =90x10^9/L; alanine transaminase / Aspertate aminotransferase=2.5 upper limit of normal range (ULN); serum creatinine=1.5 pper limit of normal range (ULN), Serum albumin=30g/L. 12. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Active multiple cancer. 2. Infectious disease. 3. Other severe complications such as ileus, intensitinal pneumonitis, pulumonary fibrosis, or ischemic heart disease 4. Probable pregnancy, and the period of lactation. 5. Difficulty to join the trial due to psychosis or psychotic symptoms. 6. Not fit to the protocol treatment by the physicion's dicision.

Design outcomes

Primary

MeasureTime frame
3 year survival;

Secondary

MeasureTime frame
treatment response rate;R0 resect rate;proportion of completion of treatment;disease relapse-free survival;

Countries

China

Contacts

Public ContactShuomeng Xiao
xiaoshuomeng2010@163.com+86 13518156853

Outcome results

None listed

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