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Active, Not Recruiting

NCT Number: NCT02384733

Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost

The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lymphedema Disease Attributes Fibrosis Hemic and Lymphatic Diseases Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denmark

About this study

The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:

63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.

The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.

The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy

Exclusion criteria

Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up

Treatment and study plan

Loco-regional RT

Radiation

Primary outcomes

  1. Development of ipsilateral arm lymphedema

    Time frame: 3 years

    >=10% increased arm circumference compared to the other arm defines edema

Secondary outcomes

  1. Fibrosis grade 2-3

    Time frame: 3 years

    Breast or chest wall induration

  2. Arm range of motion

    Time frame: 3 years

    Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction

  3. Development of dyspigmentation

    Time frame: 3 years

    Grade 2 or worse dyspigmentation compared to baseline

  4. Recurrence

    Time frame: 10 years

    Any recurrence location and time to event

  5. Development of pain in the irradiated area

    Time frame: 3 years

    Pain in the irradiated area measured on visual analog scale compared to baseline

  6. Change in sensibility

    Time frame: 3 years

    Change in sensibility in the irradiated area compared to baseline measured as yes/no

  7. Development of edema on breast / chest wall

    Time frame: 3 years

    Grade 2 or worse edema

  8. Development of telangiectasia in irradiated area

    Time frame: 3 years

    Grade 2 or worse telangiectasia

Sponsors and collaborators

Lead sponsor

Danish Breast Cancer Cooperative Group

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

The Skagen Trial 1, Moderately Hypofractionated Loco-regional Adjuvant Radiation Therapy of Early Breast Cancer Combined With a Simultaneous Integrated Boost: a Randomised Clinically Controlled Trial

Important dates

Study start
2015
Primary completion
2021
Study completion
2032
First posted
Mar 10, 2015
Registry last updated
Jul 8, 2021

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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