NCT00681967

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Feb 2004

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

5.7 years

First QC Date

May 20, 2008

Last Update Submit

September 21, 2010

Conditions

Head and Neck Cancer

Keywords

squamous cell cancer of the head & neckGefitinibIRESSAEGFR InhibitorEGFR-tyrosine kinase inhibitorSubjects with histologically proven squamous cell cancer of the head & neckCohort 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)

Outcome Measures

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 (3)

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

  • Cohort 1 only time-to-recurrence (TTR)

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

Study Arms (2)

Cohort 1

EXPERIMENTAL

post operative combination of gefinib and RT

Drug: Gefitinib

Cohort 2

EXPERIMENTAL

combination of gefitinib with RT and Chemotherapy in non operated patients

Drug: Gefitinib

Interventions

GefitinibDRUG

250 mg; oral

Also known as: IRESSA (TM)
Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Basel, Switzerland

Location

Research Site

Bern, Switzerland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Christoph Rochlitz, Prof Dr med

    University Hospital of Basel

    PRINCIPAL INVESTIGATOR

  • Madeleine Billeter, MD

    AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland

    STUDY DIRECTOR

  • Verena Renggli

    AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 21, 2008

Study Start

February 1, 2004

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

September 23, 2010

Record last verified: 2010-09

Locations

CH(2)