Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

Phase 2TerminatedNCT00237900

AstraZeneca34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Gefitinib, 5-fluorouracil, leucovorin and radiotherapyDRUG

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Reseach Site

Helsinki, Finland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509

Data from ClinicalTrials.gov

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