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:
Danish Breast Cancer Cooperative Group
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Carcinoma in Situ of the Breast |
Radiation: standard fractionated radiotherapy Radiation: hypofractionated radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Danish Breast Cancer Cooperative Group:
Primary Outcome Measures:
- Grade 2 or 3 fibrosis 3 years after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 976 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2022 |
| Estimated Primary Completion Date: | May 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
|
Radiation: standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
|
|
Experimental: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
|
Radiation: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
|
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.
Eligibility| Ages Eligible for Study: | 41 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
operated with breast conserving strategy for:
- invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909818
Contacts
| Contact: Birgitte Offersen, MD, phd | +45 8949 3333 | bvo@oncology.dk |
| Contact: Marie Overgaard, MD | +45 8949 3333 | marie@oncology.dk |
Locations
| Denmark | |
| The Danish Breast Cancer Cooperative Group | Recruiting |
| Copenhagen, Denmark, DK-2100 Ø | |
| Contact: Birgitte Offersen, MD, phd +45 8949 3333 bvo@oncology.dk | |
| Contact: Marie Overgaard, MD +45 8949 3333 marie@oncology.dk | |
| Principal Investigator: Birgitte Offersen, MD, phd | |
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Birgitte Offersen, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark |
| ClinicalTrials.gov Identifier: | NCT00909818 History of Changes |
| Other Study ID Numbers: | DBCG hypo protocol, CIRRO IP030209, The Danish Cancer Society |
| Study First Received: | May 28, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Denmark: Ethics Committee |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013