Trial Outcomes & Findings for Proton Therapy for Lymph Nodes in Breast Cancer (NCT NCT01365845)

Last Updated: 2018-06-29

Results Overview

A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

2 weeks prior to starting radiation therapy.

Results posted on

2018-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Induction Phase During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.	3D-Proton/Conventional Plan or 3D-proton Only 3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment.
Induction Phase STARTED	18	0
Induction Phase COMPLETED	18	0
Induction Phase NOT COMPLETED	0	0
Treatment Phase STARTED	0	18
Treatment Phase COMPLETED	0	18
Treatment Phase NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Therapy for Lymph Nodes in Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Patients Planned With Both Proton & Conventional Plans n=18 Participants Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment. Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
Age, Continuous	52 Years n=39 Participants
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=39 Participants
Age, Categorical >=65 years	3 Participants n=39 Participants
Sex: Female, Male Female	18 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Region of Enrollment United States	18 participants n=39 Participants

PRIMARY outcome

Timeframe: 2 weeks prior to starting radiation therapy.

A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.

Outcome measures

Outcome measures
Measure	Conventional Photon Plan n=18 Participants Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction	3D-Proton/Conventional Plan or 3D-proton Only n=18 Participants 3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction
Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)	34.7 % of heart receiving >= 5 Gray (Gy) Interval 6.9 to 60.0	2.7 % of heart receiving >= 5 Gray (Gy) Interval 0.1 to 12.3

SECONDARY outcome

Timeframe: 2 weeks prior to starting radiation therapy.

Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.

Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.

Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies. Analyze local control, progression-free survival, and overall survival.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after treatment

Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.

Outcome measures

Outcome data not reported

Adverse Events

Breast Patients Planned With Both Proton & Conventional Plans

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Breast Patients Planned With Both Proton & Conventional Plans n=18 participants at risk All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional. Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment. Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
Infections and infestations Skin infection	11.1% 2/18 • Number of events 2 • From start of radiation therapy to date of last follow-up.
Injury, poisoning and procedural complications Radiation dermatitis	22.2% 4/18 • Number of events 4 • From start of radiation therapy to date of last follow-up.

Other adverse events

Other adverse events
Measure	Breast Patients Planned With Both Proton & Conventional Plans n=18 participants at risk All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional. Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment. Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
Reproductive system and breast disorders Breast atrophy	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
Reproductive system and breast disorders Breast pain	27.8% 5/18 • Number of events 5 • From start of radiation therapy to date of last follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
Gastrointestinal disorders Esophagitis	27.8% 5/18 • Number of events 5 • From start of radiation therapy to date of last follow-up.
General disorders Fatigue	38.9% 7/18 • Number of events 7 • From start of radiation therapy to date of last follow-up.
Infections and infestations Wound infection	11.1% 2/18 • Number of events 2 • From start of radiation therapy to date of last follow-up.
Reproductive system and breast disorders Lymphedema	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
General disorders Nausea	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
Skin and subcutaneous tissue disorders Hyperpigmentation	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
Infections and infestations Infection	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.
Skin and subcutaneous tissue disorders Skin ulceration	5.6% 1/18 • Number of events 1 • From start of radiation therapy to date of last follow-up.

Additional Information

Dr. Julie Bradley

University of Florida Proton Therapy Institute

Phone: 904-588-1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place