The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients

NCT ID: NCT03270072

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-26

Study Completion Date

2026-12-31

Brief Summary

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The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation

Detailed Description

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Conditions

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Breast Cancer Stage II Breast Cancer Stage III

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Photon Therapy

The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive photon therapy.

No interventions assigned to this group

Proton Therapy

The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive proton therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Eligible for and scheduled to receive radiation therapy on Radiation Therapy Oncology Group (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial). (NCT02603341)
* Ability to understand and the willingness to sign a study-specific written informed consent document
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rachel Beth Jimenez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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17-031

Identifier Type: -

Identifier Source: org_study_id

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