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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


Phase 1/Phase 2
45 Years
70 Years
Not Enrolling
Both
Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

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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

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