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

Not Applicable

Active, not recruiting

• Conditions: Lymphedema; Fibrosis
• Interventions: Radiation: Loco-regional RT

• Registration Number: NCT02384733
• Lead Sponsor: Danish Breast Cancer Cooperative Group

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-02-19
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08
• Study Completion: 2032-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2963

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated loco-regional RT	Loco-regional RT	40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
Normofractionated loco-regional RT	Loco-regional RT	50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly

Primary Outcome Measures

Name	Time	Method
Development of ipsilateral arm lymphedema	3 years	\>=10% increased arm circumference compared to the other arm defines edema

Secondary Outcome Measures

Name	Time	Method
Fibrosis grade 2-3	3 years	Breast or chest wall induration
Arm range of motion	3 years	Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction
Development of telangiectasia in irradiated area	3 years	Grade 2 or worse telangiectasia
Development of pain in the irradiated area	3 years	Pain in the irradiated area measured on visual analog scale compared to baseline
Development of dyspigmentation	3 years	Grade 2 or worse dyspigmentation compared to baseline
Development of edema on breast / chest wall	3 years	Grade 2 or worse edema
Recurrence	10 years	Any recurrence location and time to event
Change in sensibility	3 years	Change in sensibility in the irradiated area compared to baseline measured as yes/no

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark