NCT06141070

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Standard systemic therapy + radiotherapy	Combined systemic therapy + radiation
DRUG	Standard systemic therapy	Chemoimmunotherapy or immunotherapy

Timeline

• Start date: 2023-12-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-11-21
• Last updated: 2026-04-14

Locations

6 sites across 1 country: Sweden