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NCT00909818 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00909818
Other study ID # DBCG hypo protocol
Secondary ID CIRRO IP030209Th
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 14, 2009
Est. completion date May 2024

Study information
Verified date August 2021
Source Danish Breast Cancer Cooperative Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 976
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Female
Age group 41 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark The Danish Breast Cancer Cooperative Group Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Danish Breast Cancer Cooperative Group Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Grade 2 or 3 fibrosis 3 years after radiotherapy 3 years
Secondary Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival 10 years
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