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Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Safety Issue:

No

Principal Investigator

Christoph Rochlitz, Prof Dr med

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Basel

Authority:

Switzerland: Swissmedic

Study ID:

1839IL/0525

NCT ID:

NCT00681967

Start Date:

February 2004

Completion Date:

October 2009

Related Keywords:

  • Head and Neck Cancer
  • 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)
  • Head and Neck Neoplasms

Name

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