Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery

NCT04842409 | Completed

• 1 other identifier: SAFE-FORWARD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost. All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales. Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.

Conditions

Breast Cancer; Radiotherapy Side Effect

Keywords

Breast Cancer; Radiotherapy; Safety

Outcome Measures

Primary Outcomes (2)

• Change from baseline 3-dimensional left ventricular ejection fraction (3D-LVEF) at 12 months

  Assessment of 3D-LVEF

  Baseline to 12-month

• Change from baseline Global Longitudinal Strain (GLS) at 12 months

  Assessment of GLS

  Baseline to 12-month

Interventions

Whole breast irradiation RADIATION

Whole breast irradiation using an ultra-hypofractionated schedule (26 Gy in 5 fractions)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy was allowed. Main exclusion criteria were mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost.

You may qualify if:

• Invasive and ductal carcinoma in situ (DCIS) breast cancer
• Indication to ultra-hypofractionated whole breast irradiation
• Written informed consent
• Aged more than 18 years old

You may not qualify if:

• Neoadjuvant and adjuvant chemotherapy
• Tumor bed radiation boost prescription

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Careggi, Florence University

Florence, 50134, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Icro Meattini, MD, Prof

  AOU Careggi

  PRINCIPAL INVESTIGATOR

• Lorenzo Livi, MD, Prof

  AOU Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: November 30, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IT (1)