Clinical trial NCT03270072: The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients
Official title: The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Stage II
Breast Cancer Stage III
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Change in Global Longitudinal Strain (GLS)
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography
timeFrame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
measure: Radiation-induced Lung Parenchymal Changes Using CT Imaging
timeFrame: Baseline, 3,6,12, months post treatment
measure: Incidence of Thyroid Dysfunction
timeFrame: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment
measure: Incidence of Ipsilateral Arm Lymphedema
timeFrame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
measure: Severity of Ipsilateral Arm Lymphedema
timeFrame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
measure: Ipsilateral Breast/Chest Wall Cosmesis
timeFrame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References: