NCT02384733

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,963

participants targeted

Target at P75+ for not_applicable

Timeline
75mo left

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Mar 2015Jul 2032

First Submitted

Initial submission to the registry

February 19, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2032

Expected
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

6.3 years

First QC Date

February 19, 2015

Last Update Submit

July 7, 2021

Conditions

LymphedemaFibrosis

Keywords

Radiation induced morbidity, recurrence

Outcome Measures

Primary Outcomes (1)

  • Development of ipsilateral arm lymphedema

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

    3 years

Secondary Outcomes (8)

  • Fibrosis grade 2-3

    3 years

  • Arm range of motion

    3 years

  • Development of dyspigmentation

    3 years

  • Recurrence

    10 years

  • Development of pain in the irradiated area

    3 years

  • +3 more secondary outcomes

Study Arms (2)

Hypofractionated loco-regional RT

EXPERIMENTAL

40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly

Radiation: Loco-regional RT

Normofractionated loco-regional RT

ACTIVE COMPARATOR

50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly

Radiation: Loco-regional RT

Interventions

Loco-regional RTRADIATION
Hypofractionated loco-regional RTNormofractionated loco-regional RT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

LymphedemaFibrosisRecurrence

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Lars Stenbygaard, MD

    Aalborg University Hospital

    STUDY CHAIR

  • Troels Bechmann, MD,PhD

    Vejle Hospital

    STUDY CHAIR

  • Mette Nielsen, MD

    Odense University Hospital

    STUDY CHAIR

  • Birgitte Offersen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Hanne Nielsen, MD

    Aarhus University Hospital

    STUDY CHAIR

  • Claus Kamby, MD

    Rigshospitalet, Denmark

    STUDY CHAIR

  • Sami Al-Rawi, MD

    Naestved Hospital

    STUDY CHAIR

  • Mechthild Krause, MD

    Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie

    STUDY CHAIR

  • Andreas Schreiber, MD

    Praxis für Strahlentherapie, Dresden

    STUDY CHAIR

  • Ingvil Mjaaland, MD

    Stavanger Hospital

    STUDY CHAIR

  • Tanja Marinko, MD

    Institute of Oncology Ljubljana

    STUDY CHAIR

  • Carine Kirkove, MD

    Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels

    STUDY CHAIR

  • Egil Blix, MD

    University Hospital of North Norway, Tromsoe

    STUDY CHAIR

  • Unn-Miriam Kasti

    Kristiansand Hospital, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor, ph.d.

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 10, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2021

Study Completion (Estimated)

July 1, 2032

Last Updated

July 8, 2021

Record last verified: 2021-07

Locations

DK(1)