Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib, 5-fluorouracil, leucovorin and radiotherapy | Drug |
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Oncology Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reseach Site | Helsinki | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509 |
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D013812 | Therapeutics |
Not provided
Not provided