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NCT01215162 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer

A Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target
1
Study location

NCT01215162: Completed Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.

NCT01215162 is a Phase 2 study of Breast Cancer that has completed, run by Mayo Clinic. The registered enrollment target is 65 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01215162, a Phase 2 study of Breast Cancer, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target
1
Study location

Study Summary

The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.

Conditions Studied

Breast Cancer

Interventions

  • RADIATION Intra-operative radiation to tumor bed

Study Locations (1)

Arizona

  • Mayo Clinic - Scottsdale

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2003-01
Est. Completion 2013-01
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01215162

The ClinicalTrials.gov registry entry for NCT01215162 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Intra-operative radiation to tumor bed is the first listed.

NCT01215162 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT01215162 about?

NCT01215162 is a clinical study titled "Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer". The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually gi...

What is the current status of trial NCT01215162?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2003-01. Estimated completion is 2013-01.

What conditions does trial NCT01215162 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT01215162?

The interventions under investigation include: Intra-operative radiation to tumor bed (RADIATION).

Who is sponsoring clinical trial NCT01215162?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01215162 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.