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Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
Sponsor: Vastra Gotaland Region
Summary
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.
Official title: Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer (NSCLC) and Systemic Treatment With Systemic Treatment Alone
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2023-12-01
Completion Date
2027-12-01
Last Updated
2023-11-21
Healthy Volunteers
No
Conditions
Interventions
Standard systemic therapy + radiotherapy
Combined systemic therapy + radiation
Standard systemic therapy
Chemoimmunotherapy or immunotherapy
Locations (6)
Dept of Oncology
Gothenburg, Sweden
Dept of pulmonary medicine
Linköping, Sweden
Dept of pulmonary medicine
Lund, Sweden
Dept of Oncology
Stockholm, Sweden
Dept. of Oncology
Umeå, Sweden
Dept. of Oncology
Uppsala, Sweden