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Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC

NCT00188617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-03-14

No results posted yet for this study

Summary

ELIGIBILITY

* Non-small cell lung cancer Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)\* or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung).
* Must be deemed appropriate surgical candidate
* ECOG performance status £ 2
* Age ³ 18 years
* No prior chemotherapy, radiotherapy or EGFR inhibitors

PRE-TREATMENT INVESTIGATIONS

* History, physical examination, hematology, biochemistry, toxicity/baseline symptoms: within 7 days of registration
* Radiology: CT chest within 7 days of registration
* Tumor biopsy prior to treatment

TREATMENT

* Gefitinib 250 mg will be administered orally daily x 28 days

EVALUATIONS ON TREATMENT

* Physical examination (vital signs, weight, ECOG performance status) weekly x 4
* Hematology (CBC, differential): Day 1,15, 29
* Biochemistry (creatinine, electrolytes, bilirubin, alkaline phosphatase, AST/ALT, protein): Day 1,15, 29
* Radiology: CT at baseline and after day 28
* Toxicity evaluation: continuous

DURATION OF TREATMENT

* Treatment is to be discontinued in cases of serious or unacceptable toxicity, or by patient or physician request
* Otherwise duration of therapy will be a maximum of 28 days

Conditions

Interventions

DRUG

GEFITINIB

250 mg once a day for 28 days before surgery

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Thomas Waddell, MD FRCSC · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-06-30
Completion
2009-11-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00188617 on ClinicalTrials.gov