Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

AstraZeneca

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

Treatments: Drug: Gefitinib, 5-fluorouracil, leucovorin and radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00237900

1839IL/0539

Details and patient eligibility

About

To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)