Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

NCT ID: NCT00237900

Last Updated: 2009-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2004-02-29

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Gefitinib, 5-fluorouracil, leucovorin and radiotherapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Oncology Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Reseach Site

Helsinki, , Finland

Countries

Finland

Other Identifiers

1839IL/0539

Identifier Type: -

Identifier Source: org_study_id