Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer (IRESSA&H&N)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681967

1839IL/0525

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cohort 1

Experimental group

Description:

post operative combination of gefinib and RT

Treatment:

Drug: Gefitinib

Drug: Gefitinib

Cohort 2

Experimental group

Description:

combination of gefitinib with RT and Chemotherapy in non operated patients

Treatment:

Drug: Gefitinib

Drug: Gefitinib