Clinical trial NCT02783690: A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation
Official title: A Randomized Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.


Eligibility criteria: Inclusion Criteria

* Age ≥ 18 years
* Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned.
* pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0 Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone
* ECOG Performance Status (PS) 0 to 2. (Appendix I).
* Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
* Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy.

Note: Breast implants and expanders allowed

* Able to and provides IRB approved study specific written informed consent
* Ability to complete questionnaire (s) by themselves or with assistance
* Able to complete all mandatory tests listed in section 4.0
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willing to provide tissue and blood samples for correlative research purposes.
* Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136
* Rochester patients: Willing to sign consent onto Evaluation of cardiac function in patients undergoing proton beam or photon radiotherapy, IRB number 15-007443

Exclusion Criteria:

* Medical contraindication to receipt of radiotherapy.
* Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
* Active systemic lupus or scleroderma.
* Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
* Prior receipt of ipsilateral breast or chest wall radiation that would result in significant overlap of radiation therapy fields. Prior contralateral radiotherapy for breast cancer is allowed.
* Positive margins after definitive surgery
* History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
* Inflammatory breast cancer
* Recurrent Breast Cancer
* Boosts to the chest wall after mastectomy. Nodal boosts are allowed.

Primary outcomes:
measure: Complication Rate
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of Acute Adverse Events
timeFrame: Up to 90 days post radiation therapy (RT)
measure: Incidence of Late Adverse Events
timeFrame: 90 days post-RT and up to 5 years post-RT
measure: Reconstruction Failure
timeFrame: 90 days post-RT and up to 5 years post-RT
measure: Quality of Life - Breast Cancer Outcomes
timeFrame: up to 5 years post-RT
measure: Cosmesis
timeFrame: baseline, 2 years, and 5 years
measure: Ipsilateral Breast Tumor Recurrence (IBTR) Incidence
timeFrame: at 5 years post RT
measure: Distant Recurrence Incidence
timeFrame: at 5 years post RT
measure: Regional Recurrence Incidence
timeFrame: at 5 years post RT
measure: Disease-free Survival (DFS)
timeFrame: at 5 years post RT
measure: Overall Survival (OS)
timeFrame: at 5 years post RT
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert W. Mutter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: