Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758481
Status:
RECRUITING
Last Update Posted:
2022-12-07
First Post:
2021-02-04
Brief Title:
Consolidation Conventional Radiotherapy Stereotactic Body Radiotherapy at 3 Months After First-line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients Bronchogenic carcinoma is the reason of death of almost 5500 cases every year in the Czech Republic the mortalityincidence 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 III non-randomized clinical trial Patients with stage IV NSCLC will be treated with 2-4 cycles of chemotherapy - platinum doublet cisplatinum - cDDPcarboplatinum - CBDCA Pemetrexednavelibne - NVB In cases when disease stabilization SDpartial 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 Gy16-20 fractions SBRT 30 Gy1 fractionation 50-60 Gy3-5 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
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 III non-randomized clinical trial Patients with stage IV NSCLC will be treated with 2-4 cycles of chemotherapy - platinum doublet cisplatinum - cDDPcarboplatinum - CBDCA Pemetrexednavelibne - NVB In cases when disease stabilization SDpartial 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 Gy16-20 fractions SBRT 30 Gy1 fractionation 50-60 Gy3-5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None