NCT00233636

Brief Summary

The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

6 active sites

Status
withdrawn

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

July 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

First QC Date

October 4, 2005

Last Update Submit

January 25, 2011

Conditions

Head and Neck CancerCarcinoma, Squamous Cell

Keywords

Squamous Cell Carcinoma of Head and NeckInoperable locally advanced Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

  • Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.

Secondary Outcomes (1)

  • Time to progression, Overall survival, Duration of response. Six months after Last Patient In.

Interventions

Iressa (Gefitinib)DRUG
RadiotherapyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
  • At least one measurable tumour lesion

You may not qualify if:

  • No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Aviano, Italy

Location

Research Site

Azienda, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Napoli, Italy

Location

Research Site

Palermo, Italy

Location

Research Site

Ragusa, Italy

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck

Interventions

GefitinibRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

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

Study Officials

  • AstraZeneca Italy Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

July 1, 2003

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

IT(6)