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

Lymphedema Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02384733
• Other study ID #: The Skagen Trial 1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 1, 2032

Study information

• Verified date: July 2021
• Source: Danish Breast Cancer Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2963
• Est. completion date: July 1, 2032
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Lymphedema

Intervention

Radiation:
• Loco-regional RT

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Danish Breast Cancer Cooperative Group	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of ipsilateral arm lymphedema	>=10% increased arm circumference compared to the other arm defines edema	3 years
Secondary	Fibrosis grade 2-3	Breast or chest wall induration	3 years
Secondary	Arm range of motion	Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction	3 years
Secondary	Development of dyspigmentation	Grade 2 or worse dyspigmentation compared to baseline	3 years
Secondary	Recurrence	Any recurrence location and time to event	10 years
Secondary	Development of pain in the irradiated area	Pain in the irradiated area measured on visual analog scale compared to baseline	3 years
Secondary	Change in sensibility	Change in sensibility in the irradiated area compared to baseline measured as yes/no	3 years
Secondary	Development of edema on breast / chest wall	Grade 2 or worse edema	3 years
Secondary	Development of telangiectasia in irradiated area	Grade 2 or worse telangiectasia	3 years