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NOT YET RECRUITING
NCT06141070
PHASE3

Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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

Interventions

OTHER

Standard systemic therapy + radiotherapy

Combined systemic therapy + radiation

DRUG

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