Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer
Phase 1
Terminated
- Conditions
- Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
- Registration Number
- NCT00237900
- Lead Sponsor
- AstraZeneca
- Brief Summary
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Histologically-confirmed intestinal GC (T2-T4)
- Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
- Lymph node positive or negative
- Metastasis negative
- Resection with curative intent (R0, D2)
- Chemo- and radiotherapy naïve
- Measurable lesion according RECIST
- Written informed consent
Exclusion Criteria
- Aged below 45 or over 70
- Prior gastric surgery
- Active ILD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs) Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
- Secondary Outcome Measures
Name Time Method Parts 2 and 3: Objective tumour response rate a week before surgery (CR and PR, RECIST criteria). Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509
Trial Locations
- Locations (1)
Reseach Site
🇫🇮Helsinki, Finland