CompletedPhase 1

Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

Switzerland30 participantsStarted 2004-02

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00681967

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

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