Trials / Active Not Recruiting
Active Not RecruitingNCT02384733
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
The Skagen Trial 1, Moderately Hypofractionated Loco-regional Adjuvant Radiation Therapy of Early Breast Cancer Combined With a Simultaneous Integrated Boost: a Randomised Clinically Controlled Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,963 (actual)
- Sponsor
- Danish Breast Cancer Cooperative Group · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.
Detailed description
The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are: 63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions. The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years. The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Loco-regional RT |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2021-07-01
- Completion
- 2032-07-01
- First posted
- 2015-03-10
- Last updated
- 2021-07-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02384733. Inclusion in this directory is not an endorsement.