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Completed

NCT Number: NCT00681967

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

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

250 mg; oral

Other names: IRESSA (TM)

Primary outcomes

  1. 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 outcomes

  1. Both cohorts overall survival (OS) local control (LC) rate at six months and at one year

  2. Cohort 1 only time-to-recurrence (TTR)

  3. Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: IRESSA&H&N

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
May 21, 2008
Registry last updated
Sep 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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