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Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - Trial NCT06141070

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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NCT06141070
Phase 3
Not yet recruiting
other
Trial Details
ClinicalTrials.gov โ€ข NCT06141070
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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

Study Focus

Standard systemic therapy + radiotherapy

Interventional

other

Sponsor & Location

Vastra Gotaland Region

Gothenburg,Linkรถping,Lund,Stockholm,Umeรฅ,Uppsala, Sweden

Timeline & Enrollment

Phase 3

Dec 01, 2023

Dec 01, 2027

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 (โ‰ค5
 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 lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06141070

Non-Device Trial