Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523673
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stereotactic Body Radiotherapy SBRT for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer OPPRESSA Randomized Controlled Open-label Multi-Center Phase 3 Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
OPPRESS
Brief Summary:
The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy SBRT can treat the oligo-progressive metastatic non-small cell lung cancer NSCLC after first-line chemotherapy The main questions it aims to answer are
Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy
Researchers will compare SBRT in combination with standard of care SOC and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy
Participants will
Take SBRT in combination with SOC or SOC only Visit the clinic for checkups and tests as required by the study Keep a diary of their symptoms and complete the quality of life assessment questionnaire
Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy
Researchers will compare SBRT in combination with standard of care SOC and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy
Participants will
Take SBRT in combination with SOC or SOC only Visit the clinic for checkups and tests as required by the study Keep a diary of their symptoms and complete the quality of life assessment questionnaire
Detailed Description:
This study is a prospective randomized controlled open-label multi-center phase Ⅲ study of patients with stage IV NSCLC who developed oligo-progression after prior first-line chemotherapy with clinical benefit lasting for 3 months aiming to evaluate the efficacy and safety of applying SBRT to treat oligo-progressive NSCLC
NSCLC patients with oligo-progression 5 extracranial progression sites after 3 months of clinical benefit by first-line systemic therapy and who are suitable for SBRT will be screened to meet the enrollment criteria after signing the informed consent and will be randomized to the SBRTstandard of care SOC groups according to the stratification ratio of 11
SBRT group SBRT was performed on the progressive sites During SBRT treatment maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy Evaluation was performed after completion of SBRT treatment After the occurrence of progression that is no longer suitable for SBRT treatment switch to second-line systemic therapy same as SOC
SOC group Second-line systemic therapy is based on docetaxel or albumin-paclitaxel The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician The specific drug regimen is determined in conjunction with the patients wishes Palliative radiotherapy is acceptable
NSCLC patients with oligo-progression 5 extracranial progression sites after 3 months of clinical benefit by first-line systemic therapy and who are suitable for SBRT will be screened to meet the enrollment criteria after signing the informed consent and will be randomized to the SBRTstandard of care SOC groups according to the stratification ratio of 11
SBRT group SBRT was performed on the progressive sites During SBRT treatment maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy Evaluation was performed after completion of SBRT treatment After the occurrence of progression that is no longer suitable for SBRT treatment switch to second-line systemic therapy same as SOC
SOC group Second-line systemic therapy is based on docetaxel or albumin-paclitaxel The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician The specific drug regimen is determined in conjunction with the patients wishes Palliative radiotherapy is acceptable
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