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

Danish Breast Cancer Cooperative Group (DBCG)

Status

Unknown

Conditions

Breast Cancer

Carcinoma in Situ of the Breast

Treatments

Radiation: hypofractionated radiotherapy

Radiation: standard fractionated radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00909818

DBCG hypo protocol

The Danish Cancer Society

CIRRO IP030209

Details and patient eligibility

About

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.

Full 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.

Enrollment

976 estimated patients

Sex

Female

Ages

41+ years old

Volunteers

No 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