Back to resultsPostoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer (IRESSA&H&N)
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Gefitinib
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
post operative combination of gefinib and RT
combination of gefitinib with RT and Chemotherapy in non operated patients
Outcomes
Primary Outcome Measures
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 Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681967
Brief Title
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
Acronym
IRESSA&H&N
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)., 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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
post operative combination of gefinib and RT
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
combination of gefitinib with RT and Chemotherapy in non operated patients
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
IRESSA (TM)
Intervention Description
250 mg; oral
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
IRESSA (TM)
Intervention Description
250mg; oral
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
Title
Cohort 1 only time-to-recurrence (TTR)
Title
Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Rochlitz, Prof Dr med
Organizational Affiliation
University Hospital of Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madeleine Billeter, MD
Organizational Affiliation
AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Verena Renggli
Organizational Affiliation
AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
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