Clinical trial · Interventional
Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy
Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gefitinib 500mg once daily
- description
- Gefitinib 500mg once daily
- interventionNames
- Procedure: quality-of-life assessment
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Gefitinib 500mg once daily
- interventionNames
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 4, 8, 12, 16 weeks then every 8 weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes: * Adenocarcinoma * Squamous cell cancer * Poorly differentiated epithelial malignancy * Gastroesophageal junction with Siewert type I or II tumors * Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course * Measurable or evaluable disease by CT scan * Patients with brain metastases must be stable and have received cranial irradiation prior to entry PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Serum bilirubin ≤ 3 times the upper limit of normal (ULN) * AST/ALT ≤ 2.5 times ULN (≤ 5 x in presence of liver metastases) * Able to take oral tablets (whole or dispersed) * No evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic allowed) * No known severe hypersensitivity to gefitinib or any of the excipients of this product * No prior other malignancy likely to confound results or interfere with gefitinib therapy * No medical condition considered to interfere with the safe participation in the trial * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No chemotherapy (including oral) within the past 6 weeks * No radiotherapy to site of measurable or evaluable disease within the past 4 weeks * No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications
References
Publications (0)
Data not yet available