Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06114108
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-09-22
Brief Title:
Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Phase III Randomized Controlled Trial Comparing Maintenance Systemic Therapy Alone With Systemic Therapy Plus Local Ablative Treatment for Patients With Advanced Stage IV Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
salVage
Brief Summary:
Unfortunately most patients are already at a very advanced stage when they are diagnosed with lung cancer ie the cancer has already spread outside the lungs forming metastases The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy immunotherapy to boost the bodys immune response or targeted therapy that directly hinders tumor growth In this study the aim is to find out whether it is better if after a good response to the standard therapy the remains of main tumor and the metastases are additionally treated by surgery andor radiation
Detailed Description:
In this study the aim is to find out whether after a good response to standard therapy it is better if the main tumor and metastases are additionally removed by surgery andor radiation This intervention is referred to as local ablative therapy LAT There is evidence to suggest that this additional intervention may prolong the average time to possible cancer recurrence PFS Progression-free survival or lead to longer survival on average Therefore the question is to know if these treatments prolong life and if so by how much and with what implications Currently patients who respond to initial standard therapy are not routinely offered LAT If the results of this study are positive it will lead to a fundamental change in the current standard of practice
The benefit of a therapy is not solely determined by the extension of PFS or overall survival but also heavily influenced by how the therapy impacts patients quality of life Medication side effects pain fatigue nausea or extended hospital stays can significantly diminish the perceived positive effects of a treatment from the patients viewpoint even if it appears favorable from a medical standpoint Therefore the assessment of quality of life through patient-reported outcome measures PROMs is a central aspect of this study
This study will enroll 128 patients from different Swiss hospitals randomly assigning them to either the intervention group LAT or a control group standard therapy The study is expected to span approximately two years for each patient
The benefit of a therapy is not solely determined by the extension of PFS or overall survival but also heavily influenced by how the therapy impacts patients quality of life Medication side effects pain fatigue nausea or extended hospital stays can significantly diminish the perceived positive effects of a treatment from the patients viewpoint even if it appears favorable from a medical standpoint Therefore the assessment of quality of life through patient-reported outcome measures PROMs is a central aspect of this study
This study will enroll 128 patients from different Swiss hospitals randomly assigning them to either the intervention group LAT or a control group standard therapy The study is expected to span approximately two years for each patient
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