Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02384733
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Birgitte Offersen, Danish Breast Cancer Cooperative Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Lymphedema Fibrosis Radiation: Loco-regional RT Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2036
Estimated Study Completion Date : March 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Hypofractionated loco-regional RT
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
 Radiation: Loco-regional RT
Active Comparator: Normofractionated loco-regional RT
50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
 Radiation: Loco-regional RT


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Development of ipsilateral arm lymphedema [ Time Frame: 3 years ]
    >=10% increased arm circumference compared to the other arm defines edema


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384733


Contacts
Layout table for location contacts
Contact: Birgitte V. Offersen, MD, Ph.D +45 7846 2547 birgoffe@rm.dk
Contact: Hanne M. Nielsen, MD, Ph.D +45 7846 2547 haniesen@rm.dk

Locations
Layout table for location information
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Birgitte Offersen, MD       birgoffe@rm.dk   
Contact: Hanne Nielsen, MD       haniesen@rm.dk   
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Investigators
Layout table for investigator information
Study Chair: Lars Stenbygaard, MD Aalborg University Hospital
Study Chair: Troels Bechmann, MD,PhD Vejle Hospital
Study Chair: Mette Nielsen, MD Odense University Hospital
Principal Investigator: Birgitte Offersen, MD Aarhus University Hospital
Study Chair: 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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Birgitte Offersen, MD, professor, ph.d., Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT02384733     History of Changes
Other Study ID Numbers: The Skagen Trial 1
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Birgitte Offersen, Danish Breast Cancer Cooperative Group:
Radiation induced morbidity, recurrence

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases