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NCT06141070Not yet recruiting

Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

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
Vastra Gotaland RegionPhase 3ClinicalTrials.govother
Verified
Study focus
Disease/Condition
Non Small Cell Lung Cancer
Drug/Device/Intervention
Standard systemic therapy + radiotherapy
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Vastra Gotaland Region
Location
Gothenburg,Linköping,Lund,Stockholm,Umeå,Uppsala, Sweden
Timeline & enrollment
Phase
Phase 3
Start date
Dec 01, 2023
End date
Dec 01, 2027
Enrollment
240 participants
Primary outcome

Overall survival (OS)

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.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06141070
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06141070 through Pure Global AI's free database. This Phase 3 trial is sponsored by Vastra Gotaland Region and is currently Not yet recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 240 participants.

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