Breastcancer Clinical Trial
— HAI-5-IIIOfficial title:
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
Verified date | December 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 144 |
Est. completion date | November 15, 2026 |
Est. primary completion date | November 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital, Dept. Radiotherapy-Oncology | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient preference | Patients can accept clinical trial but refuse randomization. In this case they will be allocated to a patient preference study arm, existing also of a 5 or 15 fraction-schedule. The choice of the patient: acceptance or non-acceptance of study, acceptance or non-acceptance of randomization, in case of patient preference arm: acceptance or 5 or 15 fractions. | Moment of intake, before allocation to study arm. | |
Other | QoL within perspective of cancer patients | QLQ C30 - standardised questionnaire | 4 weeks, 1, 2 and 5 years | |
Other | QoL within perspective of breast cancer patients | QLQ BR23 - standardised questionnaire | 4 weeks, 1, 2 and 5 years | |
Other | QoL within perspective of healthy patients | EQ-D5: standardised questionnaire | 4 weeks, 1, 2 and 5 years | |
Other | Number of patients evolving to higher frailty score after radiotherapy | Measurement of frailty using G8 geriatric screening tool | 4 weeks, 1, 2 and 5 years | |
Other | Cost Effectiveness Analysis | Cost effectiveness analysis comparing 5 with 15 fractions | 5 years | |
Other | Technical feasibility of prone positioning | Percentage of patients able to perform prone positioning on new breast board: yes or no. | At the moment of simulation | |
Other | Technical feasibility of deep inspirational breath-hold in prone position | Percentage of patients able to perform breath-hold procedure in prone position: yes or no. | At the moment of simulation | |
Primary | Breast retraction (LENTSOMA) | Breast Cancer Conservative treatment.core (BCCT.core) objective measurement | 2-5 years | |
Secondary | Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0) | Assessment of grade of dermatitis | 1-8 weeks | |
Secondary | Acute toxicity: number of patients with moist desquamation | CTCAE v. 4.0 (grade 3) | 1-8 weeks | |
Secondary | Acute toxicity: number of patients with pain (CTCAE v. 4.0) | Grade 1: mild; Grade 2: moderate, limiting activity of daily living (ADL); grade 3: severe, limiting ADL | 1-8 weeks | |
Secondary | Acute toxicity: number of patients with pruritus (CTCAE v. 4.0) | Grade 1: mild, localized topical intervention; Grade 2: intense, oral intervention, skin changes | 1-8 weeks | |
Secondary | Acute toxicity: number of patients with fatigue (MFI-20) | Questionnaire (20 questions) | 1-8 weeks | |
Secondary | Chronic toxicity: measurement of patient satisfaction with breast esthetic outcome | BREAST-Q questionnaire: Patient reported outcome, evaluating satisfaction with esthetic outcome. | Before radiotherapy and after 2 and 5 years | |
Secondary | Chronic toxicity: prevalence of fibrosis | LENT Soma: fibrosis (score 0-3) | 2 and 5 years | |
Secondary | Chronic toxicity: prevalence of pain | LENT Soma: score 0-4 | 2 and 5 years | |
Secondary | Chronic toxicity: prevalence of telangiectasia | LENT Soma: Score 0-3 | 2 and 5 years | |
Secondary | Chronic toxicity: prevalence of lymphedema | LENT Soma: score 0-4 | 2 and 5 years | |
Secondary | Chronic toxicity: prevalence of fatigue (MFI-20) | Questionnaire (20 questions) | 2 and 5 years | |
Secondary | Chronic toxicity - prevalence of radiation induced brachial plexopathy (RIBP) (standardized screening questionnaire), confirmed by electromyogram (EMG) | If a screening reveals unilateral pain, loss of function or muscular atrophy in the ipsilateral arm, an EMG will be performed to confirm/exclude RIBP | 2 and 5 years | |
Secondary | Loco-regional tumor control | Ipsilateral or regional breast recurrence | 2 and 5 years | |
Secondary | Distant tumor control | Distant metastases free survival | 2 and 5 years | |
Secondary | Breast cancer specific survival | Number of patients alive and without breast cancer recurrence at 2 and 5 years after adjuvant radiotherapy | 2 and 5 years | |
Secondary | Overall survival | Number of patients alive, 2 and 5 years after adjuvant radiotherapy | 2 and 5 years |
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