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CompletedNCT01243398Updated Nov 29, 2012

Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy

A Phase 3 interventional study of quality-of-life assessment in Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-29.

Sponsored by University of Oxford · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer

Keywords

  • adenocarcinoma of the gastroesophageal junction
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • recurrent esophageal cancer
  • stage IA esophageal cancer
  • stage IB esophageal cancer
  • stage IIA esophageal cancer
  • stage IIB esophageal cancer
  • stage IIIA esophageal cancer
  • stage IIIB esophageal cancer
  • stage IIIC esophageal cancer
  • stage IV esophageal cancer
03

In context

Esophageal Neoplasms

1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.

This study's enrollment of 450 is above the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Gefitinib 500mg once daily

    Gefitinib 500mg once daily

    Procedure: quality-of-life assessment

  • Placebo comparator
    Placebo

    Gefitinib 500mg once daily

    Procedure: quality-of-life assessment

Interventions

  • Procedurequality-of-life assessment
06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 4, 8, 12, 16 weeks then every 8 weeks

Secondary outcomes

  1. Toxicity and safety

    Time frame: 4, 8, 12, 16 weeks then every 8 weeks

  2. Quality of life

    Time frame: 4, 8 and 12 weeks

  3. Progression-free survival

    Time frame: 4, 8, 12, 16 weeks then every 8 weeks

07

Study locations

1 site
  • New Cross Hospital
    Wolverhampton, England WV10 0QP, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2009, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2010
First posted
Nov 18, 2010
Start
Mar 2009
Primary completionActual
May 2012
CompletionActual
May 2012
Last update
Nov 29, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01243398
Lead sponsor
University of Oxford
Responsible party
Sponsor
First posted
Nov 18, 2010
Start date
Mar 2009
Primary completion
May 2012
Completion
May 2012
Last update
Nov 29, 2012

Study contacts

David Ferry, MD
principal investigator · New Cross Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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