SBRT/RT in Oligometastatic Stage IV NSCLC
NCT05647590 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-01-30
Summary
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone.
Conditions
- Non Small Cell Lung Cancer
Interventions
- PROCEDURE
-
Chemotherapy
3 months of platinum doublet chemotherapy (cDDP / CBDCA + Pemetrexed, NVB)
- PROCEDURE
-
Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT)
* RT to primary tumor + SBRT to all oligometa (max. 10 intra / extracranial lesions, intracranial SD / PR) * SBRT V \< 100 ml, if technically possible fractionation RT (40 - 50 Gy / 16 - 20 fractions), SBRT (30 Gy / 1 fraction, 50 - 60 Gy / 3 - 5 fractions) 3 - 6 weeks … maintenance
- PROCEDURE
-
Maintenance chemotherapy
Maintenance chemotherapy will follow 3-6 weeks after RT.
Sponsors & Collaborators
-
University Hospital Ostrava
lead OTHER
Principal Investigators
-
Tereza Paračková, MD · University Hospital Ostrava
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-01
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- Czechia
Study Locations
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