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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.
Over the age of 65, uptake of adjuvant radiotherapy after surgery for breast cancer declines, even in women with poor prognostic stage or adverse tumor characteristics.
Lowering the number of fractions may reduce reluctancy for radiotherapy in this age group.
In a preceding prospective phase I-II trial, evaluating EBRT over 10 days, results on technical feasibility and acute toxicity were positively evaluated.
However, data on the chronic effects of breast irradiation using high doses per fraction are still sparse.
This trial is developed to compare standard hypo-fractionation in 15 fractions (if needed with simultaneously integrated boost - SIB) with highly accelerated radiotherapy in 5 fractions.
Patients referred for adjuvant radiotherapy after breast conserving surgery will preferably be randomized, depending on the indication, to a study-arm with whole breast irradiation (WBI) +/- SIB or to a study-arm with WBI+/- SIB and lymph node irradiation (LNI).
If patients after breast conserving surgery (BCS) have a strong preference for 5 or 15 fractions, they will be invited to enter the parallel observational arm (patient preference).
Patients referred for adjuvant radiotherapy after mastectomy +/- LNI accepting to participate, can choose a 5 or 15-fraction schedule. No randomization is foreseen in this last observational group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WBI - randomized - 5 | Experimental | WBI 5 fractions SIB 5 fractions if needed |
|
| WBI - randomized - 15 | Active Comparator | WBI 15 fractions SIB 15 fractions if needed |
|
| WBI - observational - 5 | Experimental | WBI 5 fractions SIB 5 fractions if needed |
|
| WBI - observational - 15 | Active Comparator | WBI 15 fractions SIB 15 fractions if needed |
|
| WBI + LNI - randomized - 5 | Experimental | WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions |
|
| WBI + LNI - randomized - 15 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WBI 5 fractions | Radiation | External beam radiotherapy in 5 fractions of 5,7Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast retraction (LENTSOMA) | Breast Cancer Conservative treatment.core (BCCT.core) objective measurement | 2-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0) | Assessment of grade of dermatitis | 1-8 weeks |
| Acute toxicity: number of patients with moist desquamation | CTCAE v. 4.0 (grade 3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liv Veldeman, M.D., PhD | Ghent University Hospital, Dept. Radiotherapy-Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital, Dept. Radiotherapy-Oncology | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| HAI-5 feasilibility trial: results acute toxicity | View source |
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| Active Comparator |
WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions |
|
| WBI with LNI - observational - 5 | Experimental | WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions |
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| WBI with LNI - observational - 15 | Active Comparator | WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions |
|
| thoracic wall irradiation (TWI) +/- LNI - observational - 5 | Experimental | TWI 5 fractions SIB 5 fractions if needed LNI 5 fractions |
|
| TWI +/- LNI - observational - 15 | Active Comparator | TWI 15 fractions SIB 15 fractions if needed LNI 15 fractions |
|
| WBI 15 fractions | Radiation | External beam radiotherapy in 15 fractions of 2,67Gy |
|
| LNI 5 fractions | Radiation | External beam radiotherapy in 5 fractions of 5,4Gy |
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| LNI 15 fractions | Radiation | External beam radiotherapy in 15 fractions of 2,67Gy |
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| SIB 5 fractions if needed | Radiation | Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed |
|
| SIB 15 fractions if needed | Radiation | Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed |
|
| TWI 5 fractions | Radiation | External beam radiotherapy in 5 fractions of 5,7Gy |
|
| TWI 15 fractions | Radiation | External beam radiotherapy in 15 fractions of 2,67Gy |
|
| 1-8 weeks |
| 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 |
| 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 |
| Acute toxicity: number of patients with fatigue (MFI-20) | Questionnaire (20 questions) | 1-8 weeks |
| 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 |
| Chronic toxicity: prevalence of fibrosis | LENT Soma: fibrosis (score 0-3) | 2 and 5 years |
| Chronic toxicity: prevalence of pain | LENT Soma: score 0-4 | 2 and 5 years |
| Chronic toxicity: prevalence of telangiectasia | LENT Soma: Score 0-3 | 2 and 5 years |
| Chronic toxicity: prevalence of lymphedema | LENT Soma: score 0-4 | 2 and 5 years |
| Chronic toxicity: prevalence of fatigue (MFI-20) | Questionnaire (20 questions) | 2 and 5 years |
| 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 |
| Loco-regional tumor control | Ipsilateral or regional breast recurrence | 2 and 5 years |
| Distant tumor control | Distant metastases free survival | 2 and 5 years |
| 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 |
| Overall survival | Number of patients alive, 2 and 5 years after adjuvant radiotherapy | 2 and 5 years |
| QoL within perspective of cancer patients | QLQ C30 - standardised questionnaire | 4 weeks, 1, 2 and 5 years |
| QoL within perspective of breast cancer patients | QLQ BR23 - standardised questionnaire | 4 weeks, 1, 2 and 5 years |
| QoL within perspective of healthy patients | EQ-D5: standardised questionnaire | 4 weeks, 1, 2 and 5 years |
| 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 |
| Cost Effectiveness Analysis | Cost effectiveness analysis comparing 5 with 15 fractions | 5 years |
| 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 |
| 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 |