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NCT00126555 · ClinicalTrials.gov registry record · Phase 2

Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT00126555: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00126555 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00126555, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839) with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The safety of this treatment will also be studied

Primary Outcome

Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniqu

Interventions

  • OTHER laboratory biomarker analysis
  • RADIATION Radiotherapy
  • DRUG Gefitinib
  • PROCEDURE Conventional surgery

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2005-03
Est. Completion 2013-02
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00126555 record still lists

NCT00126555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT00126555 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00126555 about?

NCT00126555 is a clinical study titled "Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer". The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839) with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The safety of this treatment will also be studied

What is the current status of trial NCT00126555?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2005-03. Estimated completion is 2013-02.

What interventions are being tested in trial NCT00126555?

The interventions under investigation include: laboratory biomarker analysis (OTHER), Radiotherapy (RADIATION), Gefitinib (DRUG), Conventional surgery (PROCEDURE).

Who is sponsoring clinical trial NCT00126555?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00126555's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00126555, the US trial registry maintained by the National Library of Medicine. NCT00126555 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.