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NCT00057746 · ClinicalTrials.gov registry record · Phase 2

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

A Phase 2 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 2
Development phase
265
Enrollment target

NCT00057746: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.

NCT00057746 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 265 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00057746, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
265 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

Primary Outcome

Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.

Interventions

  • RADIATION Prophylactic cranial irradiation, 2.5 Gy fx
  • RADIATION Prophylactic cranial irradiation, 2.0 Gy fx
  • RADIATION Prophylactic cranial irradiation, 1.5 Gy fx

Trial Details

FieldValue
Enrollment Target 265 participants
Start Date 2003-02
Est. Completion 2013-11
Phase Phase 2
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00057746 record still lists

NCT00057746 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher).

The record links to 0 conditions, and to 3 interventions - of which Prophylactic cranial irradiation, 2.5 Gy fx is the first listed.

NCT00057746 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00057746 about?

NCT00057746 is a clinical study titled "Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therap...

What is the current status of trial NCT00057746?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2003-02. Estimated completion is 2013-11.

What interventions are being tested in trial NCT00057746?

The interventions under investigation include: Prophylactic cranial irradiation, 2.5 Gy fx (RADIATION), Prophylactic cranial irradiation, 2.0 Gy fx (RADIATION), Prophylactic cranial irradiation, 1.5 Gy fx (RADIATION).

Who is sponsoring clinical trial NCT00057746?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00057746's enrollment target sits among peer trials

265 210th of 2000 higher than 1,791 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 NCT00057746, the US trial registry maintained by the National Library of Medicine. NCT00057746 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.