Phase II Iressa + Irradiation Followed by Chemo in NSCLC
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
1 other identifier
interventional
50
1 country
4
Brief Summary
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Sep 2004
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
4 active sites
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
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 2, 2006
CompletedFirst Posted
Study publicly available on registry
June 5, 2006
CompletedDecember 19, 2007
December 1, 2007
June 2, 2006
December 16, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
To estimate the objective response rate in patients treated with this drug
Secondary Outcomes (1)
Determine the safety and toxicity of this drug in these patients
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- to 75 years inclusive.
- At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
- WHO performance status of 0 to 2 inclusive.
- Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
- Life expectancy of at least 6 months.
- Using secure contraceptives precautions.
You may not qualify if:
- Any previous anti cancer therapy for NSCLC.
- Known severe hypersensitivity to these products
- Any evidence of clinically active interstitial lung disease
- Other co-existing malignancies, symptomatic metastases.
- Abnormal blood test
- Weight loss of over 15% in the 3 months before the start of the study.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
Research Site
Clermont-Ferrand, France
Research Site
Grenoble, France
Research Site
Nantes, France
Research SIte
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca France Medical Director, MD
AstraZeneca
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
June 2, 2006
First Posted
June 5, 2006
Study Start
September 1, 2004
Study Completion
January 1, 2006
Last Updated
December 19, 2007
Record last verified: 2007-12