Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

This study is currently recruiting participants.

Verified May 2009 by Danish Breast Cancer Cooperative Group

Sponsor:

Collaborator:

Danish Cancer Society

Information provided by:

Danish Breast Cancer Cooperative Group

ClinicalTrials.gov Identifier:

NCT00909818

First received: May 28, 2009

Last updated: June 22, 2011

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 28, 2009

Last Updated Date

June 22, 2011

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

May 2022 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Grade 2 or 3 fibrosis 3 years after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00909818 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

Official Title ^ICMJE

Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase II Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)

Brief Summary

The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.

Detailed Description

The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.

The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer
Carcinoma in Situ of the Breast

Intervention ^ICMJE

Radiation: standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
Radiation: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions

Study Arm (s)

Active Comparator: standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week

Intervention: Radiation: standard fractionated radiotherapy
Experimental: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions

Intervention: Radiation: hypofractionated radiotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

976

Estimated Completion Date

May 2022

Estimated Primary Completion Date

May 2022 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

operated with breast conserving strategy for:
1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR
2. carcinoma in situ of the breast

Exclusion Criteria:

previous radiation of the breast/thorax
breast implants
pregnant/lactating
comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years

Gender

Female

Ages

41 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Birgitte Offersen, MD, phd	+45 8949 3333	bvo@oncology.dk
Contact: Marie Overgaard, MD	+45 8949 3333	marie@oncology.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00909818

Other Study ID Numbers ^ICMJE

DBCG hypo protocol, CIRRO IP030209, The Danish Cancer Society

Has Data Monitoring Committee

Yes

Responsible Party

Birgitte Offersen, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark

Study Sponsor ^ICMJE

Danish Breast Cancer Cooperative Group

Collaborators ^ICMJE

Danish Cancer Society

Investigators ^ICMJE

Study Chair:	Lars Stenbygaard, MD	Aalborg Universityhospital
Study Chair:	Marie Overgaard, MD	Aarhus University Hospital
Study Chair:	Knud A Moeller, MD	Herning Hospital
Study Chair:	Erik Jakobsen, MD	Vejle Hospital
Study Chair:	Mette M Nielsen, MD, phd	Odense University Hospital
Principal Investigator:	Birgitte Offersen, MD, phd	Aarhus University Hospital

Information Provided By

Danish Breast Cancer Cooperative Group

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top