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

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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909818

Enrollment

976

Registered

2009-05-29

Start date

2009-05-14

Completion date

2024-05-31

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Carcinoma in Situ of the Breast

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.

Interventions

RADIATIONstandard fractionated radiotherapy

standard fractionated radiotherapy 50 Gy/25 fractions

RADIATIONhypofractionated radiotherapy

hypofractionated radiotherapy 40 Gy/15 fractions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

41 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Grade 2 or 3 fibrosis 3 years after radiotherapy	3 years

Secondary

Measure	Time frame
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival	10 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026