A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

Breast Cancer Clinical Trial

Official title:

A Randomized Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783690
• Other study ID #: 15-006137
• Secondary ID: MC1631
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2016
• Est. completion date: November 18, 2023

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT03391453

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 18, 2023
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Hypofractionation
40 Gy (RBE) in 15 daily fractions

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication rate, defined as grade 3 or greater late adverse events and unplanned surgical intervention in patients who undergo mastectomy with reconstruction	Will be defined as the percentage of women randomized who develop one or more of the following events: grade 3 or higher late adverse events; unplanned surgical intervention (not including planned serial fat grafting) in patients who undergo mastectomy with reconstruction.	24 months
Secondary	Incidence of Acute Adverse Events	Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.	Up to 90 days post radiation therapy (RT)
Secondary	Incidence of Late Adverse Events	Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.	90 days post-RT and up to 5 years post-RT
Secondary	Reconstruction Failure	Will assess loss of the tissue expander or implant with the inability to replace it resulting in no final reconstruction or conversion to autologous reconstruction or revised with the addition of autologous reconstruction.	90 days post-RT and up to 5 years post-RT
Secondary	Quality of life - breast cancer outcomes	measured by cosmesis evaluation and the Breast Cancer Treatment Outcome Scale (BCTOS)	up to 5 years post-RT
Secondary	Cosmesis	measured by reviewing digital photographs and the 4 point (excellent, good, fair, poor) adaptation of the Harvard Cosmesis Scale	baseline, 2 years, and 5 years
Secondary	Ipsilateral breast tumor recurrence (IBTR) Incidence	Will be defined as local recurrence from trial registration as a first event at 5 years. The IBTR cumulative incidence will be estimated using a competing risks method by treatment arm. The competing risks will be regional/distant breast cancer recurrence and death.	at 5 years post RT
Secondary	Distant Recurrence Incidence	Will assess metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer at 5 years.	at 5 years post RT
Secondary	Regional Recurrence Incidence	Defined as invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast at 5 years.	at 5 years post RT
Secondary	Disease-free Survival (DFS)	DFS is defined as the time from study registration until the occurrence, if any, of one of the following events: invasive IBTR, regional invasive breast cancer recurrence, distant breast cancer recurrence, death due to any cause, contralateral invasive breast cancer, and second primary non-breast invasive disease.	at 5 years post RT
Secondary	Overall Survival (OS)	Overall survival is defined as the time from registration to death due to any cause.	at 5 years post RT

External Links

•   Mayo Clinic Clinical Trials