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NCT00104728 · ClinicalTrials.gov registry record · NA

Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates

A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Terminated
Registry status
NA
Development phase
42
Enrollment target

NCT00104728: Clinical Trial NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00104728 is a NA study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00104728, a NA study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

TERMINATED
Registry status
NA
Development phase
42 participants
Enrollment target

Study Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.

Primary Outcome

Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.

Interventions

  • DRUG ZD1839

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2004-10
Est. Completion 2009-03
Phase NA

Why NCT00104728 stopped before completion

NCT00104728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which ZD1839 is the first listed.

NCT00104728 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00104728 about?

NCT00104728 is a clinical study titled "Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates". RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surger...

What is the current status of trial NCT00104728?

This trial is currently terminated. It is a NA study. The enrollment target is 42 participants. The study started on 2004-10. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00104728?

The interventions under investigation include: ZD1839 (DRUG).

Who is sponsoring clinical trial NCT00104728?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00104728's enrollment target sits among peer trials

42 1436th of 2000 higher than 555 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00104728, the US trial registry maintained by the National Library of Medicine. NCT00104728 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.