Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: Gefitinib (Drug); Gefitinib (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Christoph Rochlitz, Prof Dr med, Principal Investigator, Affiliation: University Hospital of Basel Madeleine Billeter, MD, Study Director, Affiliation: AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland Verena Renggli, Study Chair, Affiliation: AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
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
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Secondary outcome: Both cohorts overall survival (OS) local control (LC) rate at six months and at one yearCohort 1 only time-to-recurrence (TTR) Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Basel, Switzerland
Research Site, Bern, Switzerland
Additional Information
Starting date: February 2004
Last updated: September 21, 2010
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