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BreastcancerHAI-5-IIINCT03121248

Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years

A study testing WBI 5 fractions, WBI 15 fractions and LNI 5 fractions in people with Breastcancer, run by University Hospital, Ghent at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breastcancer
What is being tested?
WBI 5 fractions, WBI 15 fractions and LNI 5 fractions
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteBelgium
Study dates
15 Feb 2017to 15 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital, Dept. Radiotherapy-Oncology

    Ghent, 9000

Other trials in Belgium

About this study

Official 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

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.

Read the detailed description

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.

Conditions
Breastcancer
Being tested
WBI 5 fractions, WBI 15 fractions, LNI 5 fractions, LNI 15 fractions, SIB 5 fractions if needed
Keywords
Accelerated radiotherapy, Older women, Hypo-fractonation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WBI 5 fractionsRadiation

    External beam radiotherapy in 5 fractions of 5,7Gy

  • WBI 15 fractionsRadiation

    External beam radiotherapy in 15 fractions of 2,67Gy

  • LNI 5 fractionsRadiation

    External beam radiotherapy in 5 fractions of 5,4Gy

  • LNI 15 fractionsRadiation

    External beam radiotherapy in 15 fractions of 2,67Gy

  • SIB 5 fractions if neededRadiation

    Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed

  • SIB 15 fractions if neededRadiation

    Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed

  • TWI 5 fractionsRadiation

    External beam radiotherapy in 5 fractions of 5,7Gy

  • TWI 15 fractionsRadiation

    External beam radiotherapy in 15 fractions of 2,67Gy

Study groups in NCT03121248
Study groupRoleWhat they receive
WBI - randomized - 5ExperimentalWBI 5 fractions SIB 5 fractions if needed
Receives: Radiation: WBI 5 fractions; Radiation: SIB 5 fractions if needed
WBI - randomized - 15Active comparatorWBI 15 fractions SIB 15 fractions if needed
Receives: Radiation: WBI 15 fractions; Radiation: SIB 15 fractions if needed
WBI - observational - 5ExperimentalWBI 5 fractions SIB 5 fractions if needed
Receives: Radiation: WBI 5 fractions; Radiation: SIB 5 fractions if needed
WBI - observational - 15Active comparatorWBI 15 fractions SIB 15 fractions if needed
Receives: Radiation: WBI 15 fractions; Radiation: SIB 15 fractions if needed
WBI + LNI - randomized - 5ExperimentalWBI 5 fractions SIB 5 fractions if needed LNI 5 fractions
Receives: Radiation: WBI 5 fractions; Radiation: LNI 5 fractions; Radiation: SIB 5 fractions if needed
WBI + LNI - randomized - 15Active comparatorWBI 15 fractions SIB 15 fractions if needed LNI 15 fractions
Receives: Radiation: WBI 15 fractions; Radiation: LNI 15 fractions; Radiation: SIB 15 fractions if needed
WBI with LNI - observational - 5ExperimentalWBI 5 fractions SIB 5 fractions if needed LNI 5 fractions
Receives: Radiation: WBI 5 fractions; Radiation: LNI 5 fractions; Radiation: SIB 5 fractions if needed
WBI with LNI - observational - 15Active comparatorWBI 15 fractions SIB 15 fractions if needed LNI 15 fractions
Receives: Radiation: WBI 15 fractions; Radiation: LNI 15 fractions; Radiation: SIB 15 fractions if needed
thoracic wall irradiation (TWI) +/- LNI - observational - 5ExperimentalTWI 5 fractions SIB 5 fractions if needed LNI 5 fractions
Receives: Radiation: LNI 5 fractions; Radiation: TWI 5 fractions
TWI +/- LNI - observational - 15Active comparatorTWI 15 fractions SIB 15 fractions if needed LNI 15 fractions
Receives: Radiation: LNI 15 fractions; Radiation: TWI 15 fractions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast retraction (LENTSOMA)

    Breast Cancer Conservative treatment.core (BCCT.core) objective measurement

    Measured: 2-5 years

Secondary outcomes (16)

  1. Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0)

    Assessment of grade of dermatitis

    Measured: 1-8 weeks

  2. Acute toxicity: number of patients with moist desquamation

    CTCAE v. 4.0 (grade 3)

    Measured: 1-8 weeks

  3. 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

    Measured: 1-8 weeks

  4. Acute toxicity: number of patients with pruritus (CTCAE v. 4.0)

    Grade 1: mild, localized topical intervention; Grade 2: intense, oral intervention, skin changes

    Measured: 1-8 weeks

  5. Acute toxicity: number of patients with fatigue (MFI-20)

    Questionnaire (20 questions)

    Measured: 1-8 weeks

  6. Chronic toxicity: measurement of patient satisfaction with breast esthetic outcome

    BREAST-Q questionnaire: Patient reported outcome, evaluating satisfaction with esthetic outcome.

    Measured: Before radiotherapy and after 2 and 5 years

  7. Chronic toxicity: prevalence of fibrosis

    LENT Soma: fibrosis (score 0-3)

    Measured: 2 and 5 years

  8. Chronic toxicity: prevalence of pain

    LENT Soma: score 0-4

    Measured: 2 and 5 years

  9. Chronic toxicity: prevalence of telangiectasia

    LENT Soma: Score 0-3

    Measured: 2 and 5 years

  10. Chronic toxicity: prevalence of lymphedema

    LENT Soma: score 0-4

    Measured: 2 and 5 years

  11. Chronic toxicity: prevalence of fatigue (MFI-20)

    Questionnaire (20 questions)

    Measured: 2 and 5 years

  12. 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

    Measured: 2 and 5 years

  13. Loco-regional tumor control

    Ipsilateral or regional breast recurrence

    Measured: 2 and 5 years

  14. Distant tumor control

    Distant metastases free survival

    Measured: 2 and 5 years

  15. Breast cancer specific survival

    Number of patients alive and without breast cancer recurrence at 2 and 5 years after adjuvant radiotherapy

    Measured: 2 and 5 years

  16. Overall survival

    Number of patients alive, 2 and 5 years after adjuvant radiotherapy

    Measured: 2 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2017
  2. Study start15 Feb 2017
  3. Primary completion15 Nov 2021
  4. Study completion15 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121248
Sponsor's protocol ID
EC/2016/1386
Acronym
HAI-5-III
Status last verified
Dec 2023
First submitted
13 Jan 2017
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing WBI 5 fractions, WBI 15 fractions and LNI 5 fractions in people with Breastcancer, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast retraction (LENTSOMA) (time frame: 2-5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03121248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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