Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529081
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer SCLC in the advanced stage of extensive disease ED who are undergoing chemo-immunotherapy The planned study aims to assess the impact of incorporating consolidative radiotherapy into the treatment strategy focusing on residual changes following chemo-immunotherapy during immunotherapy and its effect on progression-free survival
This research experiment will be conducted as a randomized multi-center study comprising the following treatment arms
Arm I Continuation of standard of care - PDL1PD1 immunotherapy durvalumab or atezolozumab after chemo-immunotherapy based on platinum compounds
Arm II Standard of care followed by consolidating radiotherapy of the chest area and possibly metastases if indicated in doses and for palliative indications total dose of 30 Gy in 10 daily doses of 3 Gy each
Arm III Standard of care followed by consolidating radiotherapy in the radicalablative doses total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions of the chest area and all metastatic lesions
Additionally as part of routine weekly blood collections an extra volume of 10 ml of blood will be collected This additional blood sample will be obtained before starting radiotherapy during each week of radiotherapy maximum three collections and at the time of disease progression one collection resulting in a total of five extra samples The collected blood will be prepared stored and used for circulating tumor DNA ctDNA testing according to the protocol The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy
This research experiment will be conducted as a randomized multi-center study comprising the following treatment arms
Arm I Continuation of standard of care - PDL1PD1 immunotherapy durvalumab or atezolozumab after chemo-immunotherapy based on platinum compounds
Arm II Standard of care followed by consolidating radiotherapy of the chest area and possibly metastases if indicated in doses and for palliative indications total dose of 30 Gy in 10 daily doses of 3 Gy each
Arm III Standard of care followed by consolidating radiotherapy in the radicalablative doses total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions of the chest area and all metastatic lesions
Additionally as part of routine weekly blood collections an extra volume of 10 ml of blood will be collected This additional blood sample will be obtained before starting radiotherapy during each week of radiotherapy maximum three collections and at the time of disease progression one collection resulting in a total of five extra samples The collected blood will be prepared stored and used for circulating tumor DNA ctDNA testing according to the protocol The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None