Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
Conditions
Brief summary
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
Interventions
DRUGGefitinib, 5-fluorouracil, leucovorin and radiotherapy
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland
Outcome results
None listed