Trials / Completed
CompletedNCT04495309
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
Effectiveness and Tolerability of Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer: A Randomized Controlled Multinational and Multicenter Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- University Hospital Schleswig-Holstein · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The prognosis for patients with metastatic breast cancer has improved continuously. Systemic therapies alone are not able to cure the disease permanently. Investigators initiated this randomized controlled multinational and multicenter clinical trial to analyse the impact of a local metastases-directed radiotherapy in addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.
Detailed description
Preferably ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions. Larger lesions or lesions with critical normal tissue involvement should be treated with three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) in moderate hypofractionated radiotherapy (depending on the size and location of the target volume and the decision of the radiooncologist). For critical organs in the target volume, standard fractionated radiotherapy can be used.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Metastases-directed Radiotherapy | Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions |
Timeline
- Start date
- 2021-03-05
- Primary completion
- 2025-06-03
- Completion
- 2025-06-03
- First posted
- 2020-07-31
- Last updated
- 2026-02-27
Locations
14 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04495309. Inclusion in this directory is not an endorsement.