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NCT00742222 · ClinicalTrials.gov registry record · Phase 4

Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer

A Phase 4 study of Breast Cancer and Carcinoma, sponsored by Xoft.

Completed
Registry status
Phase 4
Development phase
63
Enrollment target
8
Study locations

NCT00742222 is a Phase 4 study of Breast Cancer and Carcinoma that has completed, run by Xoft. The registered enrollment target is 63 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT00742222, a Phase 4 study of Breast Cancer and Carcinoma, has completed, sponsored by Xoft.

COMPLETED
Registry status
Phase 4
Development phase
63 participants
Enrollment target
8
Study locations

Study Summary

PRINCIPAL INVESTIGATORS * Rakesh Patel, MD- Radiation Oncologist * Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN * Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients. SAMPLE SIZE AND SITES: * Approximately 400 patients may be enrolled. * Up to 100 qualified U.S. sites may participate in this registry. ENDPOINTS: 1. PRIMARY ENDPOINTS * Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. * Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. * Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways: * Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. 2. SECONDARY ENDPOINTS * Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years. This includes: * Ipsilateral recurrence within the initially treated volume. (Within the tumor bed) * Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure) * Axillary nodal recurrence * Survival - to be recorded at each follow-up visit * Overall Survival * Disease Free S

Conditions Studied

Breast Cancer Carcinoma Ductal Carcinoma In Situ Lumpectomy

Interventions

  • RADIATION Electronic Brachytherapy
  • RADIATION Intracavitary accelerated partial breast irradiation

Study Locations (8)

New Jersey

  • AtlantiCare Cancer Care Institute - Galloway
  • Nazha Cancer Center - Northfield

Alabama

  • DCH Cancer Treatment Center - Tuscaloosa

California

  • Beverly Oncology - Montebello

Florida

  • Florida Radiation Oncology Group - Orange Park

Illinois

  • St Elizabeth's and Memorial Cancer Center - Swansea

Missouri

  • Cancer Institute of Cape Girardeau - Cape Girardeau

Texas

  • Dallas Surgical Group / Northpoint Cancer Center - Dallas

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2008-05
Est. Completion 2015-01
Phase Phase 4

Sponsor

Xoft

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00742222

The ClinicalTrials.gov registry entry for NCT00742222 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 63 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 Xoft, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Electronic Brachytherapy is the first listed.

NCT00742222 reports 8 study locations spanning 7 distinct geographic areas - top geographies include New Jersey, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT00742222 about?

NCT00742222 is a clinical study titled "Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer". PRINCIPAL INVESTIGATORS * Rakesh Patel, MD- Radiation Oncologist * Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN * Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients. SAMPLE SIZE AND SITES: * Approxima...

What is the current status of trial NCT00742222?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2008-05. Estimated completion is 2015-01.

What conditions does trial NCT00742222 study?

This clinical trial studies the following conditions: Breast Cancer, Carcinoma, Ductal Carcinoma In Situ, Lumpectomy.

What interventions are being tested in trial NCT00742222?

The interventions under investigation include: Electronic Brachytherapy (RADIATION), Intracavitary accelerated partial breast irradiation (RADIATION).

Who is sponsoring clinical trial NCT00742222?

This trial is sponsored by Xoft, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00742222 being conducted?

This trial has 8 study locations across Alabama, California, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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, or report a data error.