Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study

UMIN ID: C000000246

Registered date:22/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable, locally recurrent or remnant gastric cancer
• Date of first enrollment: 2005/09/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatments consisted of chemotherapy of biweekly paclitaxel plus cisplatin and concurrent radiation for 5 weeks for unresectable, locally recurrent or remnant gastric cancer.

Outcome(s)

• Primary Outcome: Recommended dose
• Secondary Outcome: 1) Dose-limiting toxicities 2) Maximum-tolerated dose 3) The improved rate of bowel stenosis 4) The improved rate of pain relief 5) Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Local tumor is not identified by computerized tomography (CT), endoscope or gastrointestinal examination 2) Other severe medical conditions 3) Patients need treatments for bowel obstruction or bleeding 4) Obvious infection or acute inflammatory condition 5) Allergy to drugs containing Cremophor EL (including cyclosporin) 6) Brain metastases with clinical symptom 7) Women who is pregnant, lactating or have the possibility of pregnancy 8) Patients who is judged inappropriate by lead principal investigator

Related Information

• Primary Sponsor: Multi-modality therapy for gastric cancer study group
• Source(s) of Monetary Support: Non-Profit Organization ECRIN (Epidemiological and Clinical Research Information Network)