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

This study is currently recruiting participants.
Verified November 2017 by Rachel Beth Jimenez, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03270072
First Posted: September 1, 2017
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rachel Beth Jimenez, Massachusetts General Hospital
  Purpose
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

Condition
Breast Cancer Stage II Breast Cancer Stage III

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Rachel Beth Jimenez, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Global Longitudinal Strain (GLS) [ Time Frame: Baseline, 6 Months ]
    Comparison of the change in GLS between conventional radiation and proton beam radiation groups. Participants who decrease their GLS by at least 2% 6-8 months following radiation therapy will be considered to demonstrate a significant decrement in GLS.


Secondary Outcome Measures:
  • Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography [ Time Frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment ]
    Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction <50%.

  • Radiation-induced Lung Parenchymal Changes Using CT Imaging [ Time Frame: Baseline, 3,6,12, months post treatment ]
    Radiation-induced lung parenchymal changes will be assess with non-contrast enhanced computerized tomography (CT) scans and incidence will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients who do not have any changes detected, death and disease progression will be considered as competing risks.

  • Incidence of Thyroid Dysfunction [ Time Frame: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment ]
    Incidence of thyroid insufficiency will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. In the absence of thyroid dysfunction, death and disease progression will be considered as competing risks.

  • Incidence of Ipsilateral Arm Lymphedema [ Time Frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment ]
    Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.

  • Severity of Ipsilateral Arm Lymphedema [ Time Frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment ]
    Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.

  • Ipsilateral Breast/Chest Wall Cosmesis [ Time Frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment ]
    Breast cosmesis will be assessed with characteristics graded on a four-point scale. Assessments will be performed by a trained nurse/nurse practitioner using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer. Incidence of adverse cosmesis (2=fair or 3=poor score) will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients without adverse breast cosmesis, death and disease progression will be considered as competing risks.


Estimated Enrollment: 100
Actual Study Start Date: October 26, 2017
Estimated Study Completion Date: July 2027
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled at Massachusetts General Hospital on the 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).
Criteria

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

Exclusion Criteria:

  • There are no exclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270072


Contacts
Contact: Rachel Jimenez, MD 617-726-7559 RBJIMENEZ@PARTNERS.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Jimenez, MD    617-726-7559    RBJIMENEZ@Partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Rachel Jimenez, MD Massachusetts General Hospital
  More Information

Responsible Party: Rachel Beth Jimenez, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03270072     History of Changes
Other Study ID Numbers: 17-031
First Submitted: June 13, 2017
First Posted: September 1, 2017
Last Update Posted: November 13, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases