NCT04758481

Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy at 3 Months After First-line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer

Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy of All Body Locations With the Disease at 3 Months After First Line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer, Prior to Maintenance Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patients. Bronchogenic carcinoma is the reason of death of almost 5.500 cases every year in the Czech Republic, the mortality/incidence ration varies around 85%. The main cause for these unfavorable findings is the late detection of the carcinoma in late stages only (III and IV), when a long-term control of the disease is exceptional. Chemotherapy is able to prolong the life of patients with NSCLC by less than one year on average, that is why new treatment approaches are being examined.

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 radiotherapy reaches maximum precision due to the precise definition of the target volume. In some localities, management with images has been solved using modern software instruments, which are able to visualize the tumor and monitor it during the whole course of respiratory cycle. This is directly associated with minimizing radiation of healthy tissues, especially the healthy lung parenchyma. In order to define predictive factors of survival of cancer patients, it is necessary to use molecular markers. The aim of the study is to verify the feasibility of consolidation SBRT (Stereotactic Body RadioTherapy) - CyberKnife, with subsequent maintenance chemotherapy in patients with stage IV NSCLC, with max. 10 metastatic nidi. The main focus of the study will be on assessment of combination treatment toxicity. The project is a phase I/II non-randomized clinical trial. Patients with stage IV NSCLC will be treated with 2-4 cycles of chemotherapy - platinum doublet (cisplatinum - cDDP/carboplatinum - CBDCA + Pemetrexed/navelibne - NVB). In cases when disease stabilization (SD)/partial resection (PR) will be achieved, based upon restaging examinations (CT), radiotherapy (RT) of the primary tumour will follow, with lymphadenopathy and SBRT of all metastatic nidi (max. 10 intra- or extracranial metastases). Standard fractionation schemes for RT and SBRT will be used (RT 40-50 Gy/16-20 fractions, SBRT 30 Gy/1 fractionation, 50-60 Gy/3-5 fractionations). At 3-6 weeks after the end of RT, maintenance treatment will be initiated in all patients treated with Peterexed. Regular restaging examinations are planned every 3 months.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	primary tumour radiotherapy	The study subjects will undergo primary tumour radiotherapy.
RADIATION	stereotactic body radiotherapy	The study subjects will undergo stereotactic body radiotherapy.
RADIATION	maintenance radiotherapy	The study subjects will undergo maintenance radiotherapy.

Timeline

• Start date: 2021-05-04
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-02-17
• Last updated: 2022-12-07

Locations

1 site across 1 country: Czechia