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ACTIVE NOT RECRUITING Phase 3

Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

NCT01349322 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

Conditions Studied

Interventions

  • RADIATION Standard fractionation whole breast irradiation
  • RADIATION Hypofractionated whole breast irradiation
  • RADIATION Concurrent boost
  • RADIATION Sequential boost

Study Locations (20)

California

  • Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
  • Mercy San Juan Medical Center — Carmichael
  • Enloe Medical Center — Chico
  • City of Hope Comprehensive Cancer Center — Duarte
  • Epic Care-Dublin — Dublin
  • 21st Century Oncology - El Segundo — El Segundo
  • UC San Diego Moores Cancer Center — La Jolla
  • Los Angeles County-USC Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Arizona

  • 21st Century Oncology-Scottsdale — Scottsdale
  • Mayo Clinic in Arizona — Scottsdale
  • Arizona Oncology Associates-West Orange Grove — Tucson
  • Banner University Medical Center - Tucson — Tucson

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham
  • The Kirklin Clinic at Acton Road — Birmingham

Arkansas

  • CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
  • University of Arkansas for Medical Sciences — Little Rock

Trial Details

FieldValue
Enrollment Target 2,354 participants
Start Date 2011-05-24
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01349322

The ClinicalTrials.gov registry entry for NCT01349322 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Standard fractionation whole breast irradiation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01349322 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01349322 about?

NCT01349322 is a clinical study titled "Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery". RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant ...

What is the current status of trial NCT01349322?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,354 participants. The study started on 2011-05-24.

What conditions does trial NCT01349322 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01349322?

The interventions under investigation include: Standard fractionation whole breast irradiation (RADIATION), Hypofractionated whole breast irradiation (RADIATION), Concurrent boost (RADIATION), Sequential boost (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01349322?

This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01349322 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial