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ACTIVE NOT RECRUITING Phase 2

Proton Radiation for Stage II/III Breast Cancer

NCT01758445 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).

Interventions

  • RADIATION Proton Radiotherapy

Study Locations (5)

Illinois

  • Northwestern Medicine Chicago Proton Center — Warrenville

Maryland

  • Maryland Proton Treatment Center — Baltimore

New Jersey

  • Princeton ProCure Managment LLC — Somerset

Oklahoma

  • Oklahoma Proton Center — Oklahoma City

Virginia

  • Hampton University Proton Therapy Institute — Hampton

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2013-02
Est. Completion 2032-01
Phase Phase 2

Sponsor

Proton Collaborative Group

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01758445

The ClinicalTrials.gov registry entry for NCT01758445 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Proton Collaborative Group, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which Proton Radiotherapy 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: NCT01758445 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Maryland, New Jersey. 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 NCT01758445 about?

NCT01758445 is a clinical study titled "Proton Radiation for Stage II/III Breast Cancer". The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of ...

What is the current status of trial NCT01758445?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2013-02. Estimated completion is 2032-01.

What conditions does trial NCT01758445 study?

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

What interventions are being tested in trial NCT01758445?

The interventions under investigation include: Proton Radiotherapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01758445?

This trial is sponsored by Proton Collaborative Group, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01758445 being conducted?

This trial has 5 study locations across Illinois, Maryland, New Jersey, Oklahoma, Virginia. 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