Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation

NCT04909125 | Active Not Recruiting

• 1 other identifier: SVIFT Nodal Trial
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy

Conditions

Breast Cancer; Post Mastectomy

Keywords

radiotherapy; hypofractionation; quality of life

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Changes in patient reported fatigue at six weeks post commencing radiotherapy compared to baseline fatigue score. Fatigue score is rated as fatigue that interfered with patients' normal daily activities from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome

  six weeks post radiation treatment

Secondary Outcomes (7)

• Changes in patients' quality of life

  first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years

• Number of participants with acute radiation dermatitis in irradiated area

  During treatment

• Number of participants with ipsilateral arm lymphoedema

  3 years post radiation treatment

• Number of participants with ipsilateral arm range of motion

  3 years post radiation treatment

• Disease Recurrence

  5 years from treatment

Study Arms (2)

Hypofractionation Arm

ACTIVE COMPARATOR

40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight)

Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy

Standard /Conventional fractionation Arm

OTHER

50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight)

Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy

Interventions

Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy RADIATION

The purpose of this study is to investigate toxicity following standard conventional fractionation versus moderately hypofractionated radiotherapy to the breast, chest wall and regional lymph nodes

Hypofractionation Arm; Standard /Conventional fractionation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• ECOG performance status 0-2
• Ability to understand and willingness to sign a written informed consent document
• Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing
• Managed with either mastectomy or breast conserving surgery
• Suitable for radiation therapy to the breast/chest wall and regional lymph nodes
• Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted
• Neoadjuvant radiotherapy (reverse sequencing) accepted
• Breast implants and expanders are accepted
• Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated
• Life expectancy minimum 10 years
• Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment)

You may not qualify if:

• Prior radiotherapy to the ipsilateral breast or chest wall
• Pregnancy or lactation
• Radiosensitivity syndrome
• Permanent pacemaker/defibrillator within radiotherapy field
• Oncoplastic surgery where boost volume unacceptable (clinician discretion)
• Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)

Sponsors & Collaborators

• Royal North Shore Hospital: lead
• Northern Sydney and Central Coast Area Health Service: collaborator

Study Sites (1)

Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Susan Carroll, MBBS FRANZCR

  Radiation Oncology Department, Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be randomised to one of the arms and will be notified for the randomization results. Randomisation ratio 2:1 (hypofractionation : standard)
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: June 1, 2021
• Primary Completion: July 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)