Head and Neck CancerPhase 2NCT00233636
Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing Iressa (Gefitinib) and Radiotherapy in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by AstraZeneca at 6 sites in Italy.
Trial summary
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Carcinoma, Squamous Cell
- What is being tested?
- Iressa (Gefitinib) and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 6 sitesItaly
- Study dates
- Jul 2003to not given
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
- At least one measurable tumour lesion
Who cannot join
- No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Research Site
Aviano
Research Site
Azienda
Research Site
Milan
Research Site
Naples
Research Site
Palermo
Research Site
Ragusa
About this study
Official title: A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous Cell
- Being tested
- Iressa (Gefitinib), Radiotherapy
- Keywords
- Squamous Cell Carcinoma of Head and Neck, Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iressa (Gefitinib)Drug
RadiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Secondary outcomes (1)
Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Italy Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233636
- Sponsor's protocol ID
- 1839IL/0070
- Status last verified
- Jan 2011
- First submitted
- 4 Oct 2005
- Last updated
- 27 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck
- ClinicalTrials.gov ID
- NCT00233636
- Acronym / sponsor ID
- 1839IL/0070
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous Cell
- Keywords
- Squamous Cell Carcinoma of Head and Neck, Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 28 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- First posted
- 6 Oct 2005 (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.
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
- At least one measurable tumour lesion
Key exclusion criteria (3 listed)
- No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
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 |
|---|---|---|
| Iressa (Gefitinib) | Drug | – |
| Radiotherapy | Procedure or surgery | – |
Primary outcome
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
1 secondary outcome
Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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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.
AstraZeneca Italy Medical Director, MD study director
AstraZeneca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iressa (Gefitinib) and Radiotherapy in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by AstraZeneca at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.. 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 27 Jan 2011.