Adenocarcinoma of the Gastroesophageal JunctionPhase 3NCT01243398
Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy
A Phase 3 study testing quality-of-life assessment in people with Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer
- What is being tested?
- quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
New Cross Hospital
Wolverhampton, England, WV10 0QP
About this study
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.
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.
- Being tested
- quality-of-life assessment
- 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
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib 500mg once daily | Experimental | Gefitinib 500mg once daily Receives: Procedure: quality-of-life assessment |
| Placebo | Placebo comparator | Gefitinib 500mg once daily Receives: Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 4, 8, 12, 16 weeks then every 8 weeks
Secondary outcomes (3)
Toxicity and safety
Measured: 4, 8, 12, 16 weeks then every 8 weeks
Quality of life
Measured: 4, 8 and 12 weeks
Progression-free survival
Measured: 4, 8, 12, 16 weeks then every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startMar 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Gastroesophageal JunctionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ferry, MD, Principal investigator, New Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243398
- Sponsor's protocol ID
- CDR0000689080
- Other IDs
- OXFORD-COG, UO-COG, EUDRACT-2007-005391-13, ISRCTN-29580179, AZ-D7913L00059, EU-21085
- Status last verified
- Nov 2012
- First submitted
- 17 Nov 2010
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
- ClinicalTrials.gov ID
- NCT01243398
- Acronym / sponsor ID
- CDR0000689080
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gefitinib 500mg once daily | Experimental | Procedure: quality-of-life assessmentGefitinib 500mg once daily |
| Placebo | Placebo comparator | Procedure: quality-of-life assessmentGefitinib 500mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | Gefitinib 500mg once daily, Placebo |
Primary outcome
Overall survival
Time frame: 4, 8, 12, 16 weeks then every 8 weeks
3 secondary outcomes
Toxicity and safety
Time frame: 4, 8, 12, 16 weeks then every 8 weeks
Quality of life
Time frame: 4, 8 and 12 weeks
Progression-free survival
Time frame: 4, 8, 12, 16 weeks then every 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ferry, MD principal investigator
New Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quality-of-life assessment in people with Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 4, 8, 12, 16 weeks then every 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.