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Phase II Randomised Control Study of Neoadjuvant Docetaxel/Oxaliplatin/Xelode (DOX) in Locally Advanced Gastric Cancer

Phase II Randomised Control Study of Neoadjuvant Docetaxel/Oxaliplatin/Xelode (DOX) in Locally Advanced Gastric Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005415
Enrollment
Unknown
Registered
2014-10-28
Start date
2014-10-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

gastric cancer

Interventions

neoadjuvant group:neoadjuvant Docetaxel/Oxaliplatin/Xelode (DOX)
Control:Neoadjuvant Docetaxel/Oxaliplatin/Xelode (DOX) three weeks and eight weeks courses

Sponsors

the First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteers with informed consent; 2. To be aged 18 to 75 years old; 3. ECOG score less than 0-1; 4. fertile woman accepted for contraception during the study; 5. gastric cancer confirmed by histology; 6. preoperative staging is T4N+M0 with CT and ultrasonic endoscope, and possibly resectable; 7. without distant metastasis, without para-aortic lymph node metastasis; 8. maximum diameter more than at least 1cm measured by spiral CT, or more than at least 2cm measured by normal CT/MRI; 9. without neoadjuvant chemotherapy before this study; 10. hepatorenal bone marrow functions suitable for chemotherapy; 11. suitalbe for abdominal surgery.

Exclusion criteria

Exclusion criteria: 1. To be aged younger than 18 or older than 75 years old; 2. ECOG score more than 1; 3. suspicious distant metastasis; 4. unsuitable for chemotherapy; 5. severe gastrointestinal bleeding; 6. tumor with deep ulcer; 7. with severe cardiovascular disease, hepatorenal disfunction, neuropsychiatric disease or acute infection; 8. poorly controlled diabetes and hypertension; 9. pregnant orlactating women; 10. unwilling for contraception; 11. malabsorption or upper gastrointestinal tract obstruction.

Design outcomes

Primary

MeasureTime frame
Radical resection rate;

Secondary

MeasureTime frame
recurrence-free survival;Chemotherapy reaction;

Countries

China

Contacts

Public ContactZekuan Xu

the First Affiliated Hospital of Nanjing Medical University

xuzekuan@njmu.edu.cn+86 13809031818

Outcome results

None listed

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