Head and Neck CancerPhase 1IRESSA&H&NNCT00681967
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
A Phase 1 study testing Gefitinib in people with Head and Neck Cancer, run by AstraZeneca at 2 sites in Switzerland.
Trial summary
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2004to Oct 2009
- Phase
- Phase 1
- 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
- Written informed consent
- Age over 18 years
- Histologically proven squamous cell cancer of the head \& neck (SCCHN)
- Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3
Who cannot join
- Hypersensitivity to ZD1839 or any of the excipients of this product
- Tumour stage M1
- Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
- Absolute neutrophil counts <1.5 x 109
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
- Conditions
- Head and Neck Cancer
- Being tested
- Gefitinib
- Keywords
- squamous cell cancer of the head & neck, Gefitinib, IRESSA, EGFR Inhibitor, EGFR-tyrosine kinase inhibitor, Subjects with histologically proven squamous cell cancer of the head & neck, Cohort 1:qualifying for postoperative radiotherapy, (pT3, pT4, pN2b, pN2c, pN3)., Cohort 2:qualifying for definite chemoradiotherapy, (Lateral oropharynx, tonsils: T1N2b-3, T2N1-3, T3any N;, Base of tongue, vallecula: T1N1-3, T2-4 any N; Oral cavity,, glottic and supraglottic larynx; Any TN1-3, T3-4 any N;, Hypopharynx: T1N1-3, T2-4 and N)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | post operative combination of gefinib and RT Receives: Drug: Gefitinib |
| Cohort 2 | Experimental | combination of gefitinib with RT and Chemotherapy in non operated patients Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
Secondary outcomes (3)
Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
Cohort 1 only time-to-recurrence (TTR)
Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startFeb 2004
- Primary completionOct 2009
- Study completionOct 2009
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Rochlitz, Prof Dr med, Principal investigator, University Hospital of BaselMadeleine Billeter, MD, Study director, AstraZeneca AG, Grafenau 10; 6300 Zug; SwitzerlandVerena Renggli, Study chair, AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681967
- Sponsor's protocol ID
- 1839IL/0525
- Acronym
- IRESSA&H&N
- Status last verified
- Sep 2010
- First submitted
- 20 May 2008
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial
- ClinicalTrials.gov ID
- NCT00681967
- Acronym / sponsor ID
- IRESSA&H&N / 1839IL/0525
- Conditions
- Head and Neck Cancer
- Keywords
- squamous cell cancer of the head & neck, Gefitinib, IRESSA, EGFR Inhibitor, EGFR-tyrosine kinase inhibitor, Subjects with histologically proven squamous cell cancer of the head & neck, Cohort 1:qualifying for postoperative radiotherapy, (pT3, pT4, pN2b, pN2c, pN3).
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 May 2008 (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.
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Gefitinibpost operative combination of gefinib and RT |
| Cohort 2 | Experimental | Drug: Gefitinibcombination of gefitinib with RT and Chemotherapy in non operated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age over 18 years
- Histologically proven squamous cell cancer of the head \& neck (SCCHN)
- Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3
Key exclusion criteria (4 listed)
- Hypersensitivity to ZD1839 or any of the excipients of this product
- Tumour stage M1
- Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
- Absolute neutrophil counts <1.5 x 109
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 |
|---|---|---|
| GefitinibAlso: IRESSA (TM)250 mg; oral | Drug | Cohort 1 |
| GefitinibAlso: IRESSA (TM)250mg; oral | Drug | Cohort 2 |
Primary outcome
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
3 secondary outcomes
Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
Cohort 1 only time-to-recurrence (TTR)
Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)
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 23 Sep 2010.
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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.
Christoph Rochlitz, Prof Dr med principal investigator
University Hospital of Basel
Madeleine Billeter, MD study director
AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Verena Renggli study chair
AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gefitinib in people with Head and Neck Cancer, run by AstraZeneca at 2 sites in Switzerland.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa. 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 23 Sep 2010.