Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years
HAI-5-III
A Partially Randomized Patient Preference Trial, Comparing Adjuvant Hypofractionated Radiotherapy in 15 Versus 5 Fractions After Breast Conserving Surgery or Mastectomy for Early or Locally Advanced Breast Cancer in Women Above 65 Years
1 other identifier
interventional
144
1 country
1
Brief Summary
This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer. Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2017
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
ExpectedDecember 22, 2023
December 1, 2023
4.8 years
January 13, 2017
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breast retraction (LENTSOMA)
Breast Cancer Conservative treatment.core (BCCT.core) objective measurement
2-5 years
Secondary Outcomes (16)
Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0)
1-8 weeks
Acute toxicity: number of patients with moist desquamation
1-8 weeks
Acute toxicity: number of patients with pain (CTCAE v. 4.0)
1-8 weeks
Acute toxicity: number of patients with pruritus (CTCAE v. 4.0)
1-8 weeks
Acute toxicity: number of patients with fatigue (MFI-20)
1-8 weeks
- +11 more secondary outcomes
Other Outcomes (8)
Patient preference
Moment of intake, before allocation to study arm.
QoL within perspective of cancer patients
4 weeks, 1, 2 and 5 years
QoL within perspective of breast cancer patients
4 weeks, 1, 2 and 5 years
- +5 more other outcomes
Study Arms (10)
WBI - randomized - 5
EXPERIMENTALWBI 5 fractions SIB 5 fractions if needed
WBI - randomized - 15
ACTIVE COMPARATORWBI 15 fractions SIB 15 fractions if needed
WBI - observational - 5
EXPERIMENTALWBI 5 fractions SIB 5 fractions if needed
WBI - observational - 15
ACTIVE COMPARATORWBI 15 fractions SIB 15 fractions if needed
WBI + LNI - randomized - 5
EXPERIMENTALWBI 5 fractions SIB 5 fractions if needed LNI 5 fractions
WBI + LNI - randomized - 15
ACTIVE COMPARATORWBI 15 fractions SIB 15 fractions if needed LNI 15 fractions
WBI with LNI - observational - 5
EXPERIMENTALWBI 5 fractions SIB 5 fractions if needed LNI 5 fractions
WBI with LNI - observational - 15
ACTIVE COMPARATORWBI 15 fractions SIB 15 fractions if needed LNI 15 fractions
thoracic wall irradiation (TWI) +/- LNI - observational - 5
EXPERIMENTALTWI 5 fractions SIB 5 fractions if needed LNI 5 fractions
TWI +/- LNI - observational - 15
ACTIVE COMPARATORTWI 15 fractions SIB 15 fractions if needed LNI 15 fractions
Interventions
External beam radiotherapy in 5 fractions of 5,7Gy
External beam radiotherapy in 15 fractions of 2,67Gy
External beam radiotherapy in 5 fractions of 5,4Gy
External beam radiotherapy in 15 fractions of 2,67Gy
Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
External beam radiotherapy in 5 fractions of 5,7Gy
External beam radiotherapy in 15 fractions of 2,67Gy
Eligibility Criteria
You may qualify if:
- breast conserving surgery or mastectomy for breast carcinoma
- multidisciplinary decision of adjuvant irradiation
- absence of distant metastases
- informed consent obtained, signed and dated before specific protocol procedures
You may not qualify if:
- History of previous radiation treatment to the same region
- Bilateral breast irradiation
- Life expectancy of less than 2 years
- Planned reconstructive breast surgery
- Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, …
- Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ghent University Hospital, Dept. Radiotherapy-Oncology
Ghent, 9000, Belgium
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Liv Veldeman, M.D., PhD
Ghent University Hospital, Dept. Radiotherapy-Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2017
First Posted
April 20, 2017
Study Start
February 15, 2017
Primary Completion
November 15, 2021
Study Completion (Estimated)
November 15, 2026
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share