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NCT01082211 · ClinicalTrials.gov registry record · Phase 2

Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

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

Completed
Registry status
Phase 2
Development phase
65
Enrollment target

NCT01082211: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.

NCT01082211 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01082211, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.

Primary Outcome

Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest,

Interventions

  • RADIATION 3D-Conformal External Beam

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2010-06
Est. Completion 2022-05-20
Phase Phase 2
Radiation Therapy Oncology Group

144 total trials

What the finished NCT01082211 record still lists

NCT01082211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).

The record links to 0 conditions, and to 1 intervention - of which 3D-Conformal External Beam is the first listed.

NCT01082211 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01082211 about?

NCT01082211 is a clinical study titled "Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with local...

What is the current status of trial NCT01082211?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2010-06. Estimated completion is 2022-05-20.

What interventions are being tested in trial NCT01082211?

The interventions under investigation include: 3D-Conformal External Beam (RADIATION).

Who is sponsoring clinical trial NCT01082211?

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 NCT01082211's enrollment target sits among peer trials

65 987th of 2000 higher than 1,005 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 NCT01082211, the US trial registry maintained by the National Library of Medicine. NCT01082211 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.