Clinical trial · Interventional
Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer
An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer
NCT00237900CI-TRIAL-00002240terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib, 5-fluorouracil, leucovorin and radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
- measure
- Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
Secondary outcomes (4)
- measure
- Parts 2 and 3:
- measure
- Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
- measure
- Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
- measure
- Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.