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NCT Number: NCT03121248

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breastcancer

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital, Dept. Radiotherapy-Oncology

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WBI 5 fractions

Radiation

External beam radiotherapy in 5 fractions of 5,7Gy

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

LNI 15 fractions

Radiation

External beam radiotherapy in 15 fractions of 2,67Gy

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

Primary outcomes

  1. Breast retraction (LENTSOMA)

    Time frame: 2-5 years

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

Secondary outcomes

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

    Time frame: 1-8 weeks

    Assessment of grade of dermatitis

  2. Acute toxicity: number of patients with moist desquamation

    Time frame: 1-8 weeks

    CTCAE v. 4.0 (grade 3)

  3. Acute toxicity: number of patients with pain (CTCAE v. 4.0)

    Time frame: 1-8 weeks

    Grade 1: mild; Grade 2: moderate, limiting activity of daily living (ADL); grade 3: severe, limiting ADL

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

    Time frame: 1-8 weeks

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

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

    Time frame: 1-8 weeks

    Questionnaire (20 questions)

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

    Time frame: Before radiotherapy and after 2 and 5 years

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

  7. Chronic toxicity: prevalence of fibrosis

    Time frame: 2 and 5 years

    LENT Soma: fibrosis (score 0-3)

  8. Chronic toxicity: prevalence of pain

    Time frame: 2 and 5 years

    LENT Soma: score 0-4

  9. Chronic toxicity: prevalence of telangiectasia

    Time frame: 2 and 5 years

    LENT Soma: Score 0-3

  10. Chronic toxicity: prevalence of lymphedema

    Time frame: 2 and 5 years

    LENT Soma: score 0-4

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

    Time frame: 2 and 5 years

    Questionnaire (20 questions)

  12. Chronic toxicity - prevalence of radiation induced brachial plexopathy (RIBP) (standardized screening questionnaire), confirmed by electromyogram (EMG)

    Time frame: 2 and 5 years

    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

  13. Loco-regional tumor control

    Time frame: 2 and 5 years

    Ipsilateral or regional breast recurrence

  14. Distant tumor control

    Time frame: 2 and 5 years

    Distant metastases free survival

  15. Breast cancer specific survival

    Time frame: 2 and 5 years

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

  16. Overall survival

    Time frame: 2 and 5 years

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

Other outcomes

  1. Patient preference

    Time frame: Moment of intake, before allocation to study arm.

    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.

  2. QoL within perspective of cancer patients

    Time frame: 4 weeks, 1, 2 and 5 years

    QLQ C30 - standardised questionnaire

  3. QoL within perspective of breast cancer patients

    Time frame: 4 weeks, 1, 2 and 5 years

    QLQ BR23 - standardised questionnaire

  4. QoL within perspective of healthy patients

    Time frame: 4 weeks, 1, 2 and 5 years

    EQ-D5: standardised questionnaire

  5. Number of patients evolving to higher frailty score after radiotherapy

    Time frame: 4 weeks, 1, 2 and 5 years

    Measurement of frailty using G8 geriatric screening tool

  6. Cost Effectiveness Analysis

    Time frame: 5 years

    Cost effectiveness analysis comparing 5 with 15 fractions

  7. Technical feasibility of prone positioning

    Time frame: At the moment of simulation

    Percentage of patients able to perform prone positioning on new breast board: yes or no.

  8. Technical feasibility of deep inspirational breath-hold in prone position

    Time frame: At the moment of simulation

    Percentage of patients able to perform breath-hold procedure in prone position: yes or no.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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

Acronym: HAI-5-III

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
Apr 20, 2017
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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