CompletedPhase 3

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

United Kingdom450 participantsStarted 2009-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

Timeframe: 4, 8, 12, 16 weeks then every 8 weeks

Trial details

NCT IDNCT01243398

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Adenocarcinoma of the Gastroesophageal Junction trials