Hypofractionated Radiotherapy After Breast Conserving Surgery

Breast Cancer Clinical Trial

— MC1635  

Official title:

A Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03339934
• Other study ID #: 16-008600
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2017
• Last updated: March 29, 2018
• Start date: March 27, 2017
• Est. completion date: July 8, 2023

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.

Description:

Primary Objectives

To determine the 24-month complication rate of 25Gy in 5 fractions whole radiotherapy +/- concurrent boost as compared to 40Gy in 15 fraction radiotherapy +/- sequential boost. Complications will be defined as one or more of the following events: 1) grade 3 or higher late adverse event, 2) deterioration of cosmesis from excellent/good to fair/poor or from fair to poor.

ARM 1: Conventional hypofractionation 40 Gy (RBE) / Gy in 15 daily fractions with optional 10 Gy (RBE) / Gy in 4 fractions sequential boost to a total dose of 50 Gy in 19 fractions; or a concomitant boost to total dose of 48Gy in 15 daily fractions.(n=41)

ARM 2: 5 Fraction Hypofractionation 25 Gy (RBE) / Gy in 5 daily fractions with optional concurrent boost to a total dose of 30 Gy (RBE) / Gy in 5 fractions (n=41)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: July 8, 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological confirmation of breast cancer.

• Pathologic Stage T0-T3N0-N1M0.

• ECOG Performance Status (PS) 0 to 2. (Appendix I).

• Able to and provides IRB approved study specific written informed consent.

• Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable).

• 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).

• Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale.

• Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy.

• Breast conserving surgery and indications for whole breast radiotherapy.

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.

• Prior receipt of ipsilateral breast or chest wall radiation.

• Positive margins on ink after definitive surgery either for DCIS or invasive cancer.

• 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.

• Recurrent breast cancer.

• Indications for comprehensive regional nodal irradiation.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Hypofractionation
25Gy in 5tx to the whole breast

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 of 5 Fraction vs. 15 Fraction Whole Radiatherapy	To determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost. Complications will be defined as one or more of the following events: 1) grade 3 or higher late adverse event (CTCAE v. 4.0) 2) deterioration of cosmesis from excellent/good to fair/poor or from fair to poor (Harvard cosmesis scale)	24 months