Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
Principal Investigator
AstraZeneca Oncology Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Finland: Finnish Medicines Agency
Study ID:
1839IL/0539
NCT ID:
NCT00237900
Start Date:
July 2003
Completion Date:
February 2004
Related Keywords:
- Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
- Stomach Neoplasms