EUCTR2010-020189-37-IT
Active, not recruiting
Not Applicable
A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer - IRST 151.01
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patient with potentially resectable adenocarcinoma of the stomach
- Sponsor
- ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female 18\-75 years of age
- •Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
- •cT3 subserosal \- cT4a – cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
- •ECOG performance status 0\-1 at study entry
- •Laboratory requirements (up to 8 days prior to randomization):
- •a) Haematology:
- •I) Neutrophils \> 1\.5 x 109 /L
- •II) Platelets \> 100 x 109 /L
- •III) Hemoglobin \> 10g/dL
- •b) Hepatic function
Exclusion Criteria
- •Early gastric cancer (if N0\)
- •T2 (according to 7th edition of UICC TNM) if N0
- •Linitis plastica
- •Positive peritoneal cytology
- •Distant metastases
- •Tumor involving the gastro\-esophageal junction
- •Peritoneal involvement
- •Concurrent chronic systemic immune therapy
- •Any investigational agent(s) 4 weeks prior to study entry
- •Clinically relevant coronary artery disease, a history of myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months
Outcomes
Primary Outcomes
Not specified
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