Status:
UNKNOWN
Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy at 3 Months After First-line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer
Lead Sponsor:
University Hospital Ostrava
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lung cancer is the main cause of death among cancer diseases, in the Czech Republic, as well as worldwide. Non-small cell lung cancer (NSCLC) is responsible for more than 80% of deaths among cancer pa...
Detailed Description
The basic treatment modality of lung cancer is radiotherapy, which has a proven therapeutic benefit in radical and palliative indications in up to 76% of all patients. Stereotactic robotic radiotherap...
Eligibility Criteria
Inclusion
- Patients with previously untreated, non-resectable, stage IV NSCLC verified with histology or cytology (according to American Joint Committee on Cancer Version 8).
- Patients must undergo 2-4 cycles of first-line chemotherapy, with the effect of disease stabilization or partial response.
- Patients over 18 years of age.
- Patients with measureable disease (on CT, PET/CT, MRI).
- Patients with 3-10 extracranial/intracranial lesions confirmed on CT, PET/CT, MRI, max. 4 weeks prior to start of SBRT.
- Max. 10 irradiated volumes (primary tumour + lymphadenopathy in one volume, if technically feasible).
- Performance status (PS) 0-2 according to ECOG. Assessment of PS max. 7 days prior to start of treatment.
- AST, ALT \& ALP ≤ 2.5x norm. Total bilirubin must be within the normal range. 9. Normal function of bone marrow - Adiponectin ≥ 1.5, Haemoglobin ≥ 100, thrombo ≥ 100.
- Serum creatinine ≤1.5x norm.
- The entry laboratory tests must not be older than 14 days prior to start of treatment.
- Negative pregnancy test and use of contraception in women of childbearing age.
- Patients undergoing SBRT for pulmonary nidi must undergo entry spirometry with the value FEV1 (forced expiratory volume in 1 second) ≥ 1L.
- Patients must sign informed consent.
Exclusion
- Patients with small-cell lung cancer or with mixed aetiology with SCLC.
- Serious ongoing infections.
- Patients with a history of haematopoiesis disorders.
- Weight loss exceeding 10% within the last 3 months.
- Patients with skin metastases of NSCLC.
- Patients treated for other malignity within the last 5 years
- Patients with more than 10 extracranial/intracranial metastases.
- Malignant fluidothorax \> 1 cm prior to start of treatment.
- Patients treated with targeted treatment for EGFR mutation or EML-4-ALK translocation in the 1st-line (Erlotinib, Gefitinib, Afatinib, Crizotinib, …).
- Patients treated with immunotherapy (anti-PD-1, anti-PD-L1 or anti-PD-L2, anti CTLA-4, …).
- Participation in another clinical trial within the last month before the start of NSCLC treatment.
- Inability to cooperate or comply with the study protocol.
- Decision of the patient to discontinue participation in the study.
- Pregnant women.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04758481
Start Date
May 4 2021
End Date
December 31 2023
Last Update
December 7 2022
Active Locations (1)
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1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852