Esophageal Cancer Clinical Trial
Official title:
Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether
gefitinib is more effective than a placebo in treating esophageal cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works
compared with a placebo in treating patients with esophageal cancer that is progressing
after chemotherapy.
OBJECTIVES:
Primary
- To assess whether gefitinib vs placebo will improve overall survival of patients with
esophageal or gastroesophageal junction cancer.
Secondary
- To assess the toxicity of gefitinib monotherapy in these patients.
- To assess whether gefitinib vs placebo will have a significant positive or negative
impact upon quality of life of these patients.
- To assess the impact gefitinib vs placebo will have on progression-free survival of
these patients.
OUTLINE: This is a multicenter study.
- Arm A: Patients receive oral gefitinib once daily. Treatment continues in the absence
of disease progression or unacceptable toxicity.
- Arm B: Patients receive oral placebo once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Blood samples are collected for genetic and translational studies. Patient's quality of life
is assessed at baseline and periodically during the study with completion of EORTC Quality
of Life Questionnaire (QLQ-C30) version 3.0.
After completion of study treatment, patients are followed up every 8 weeks.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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