Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102057
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-09-08
Brief Title:
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
Sponsor:
TheraOp
Organization:
TheraOp
Study Overview
Official Title:
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PACCELIO
Brief Summary:
Multinational randomized controlled open-label multicenter phase II trial Eligible patients will be randomized in a ratio of 11 to Experimental Arm FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy or Conventional Arm standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy Patients showing complete response partial response or stable disease following chemoradiotherapy will receive standard of care consolidation therapy with durvalumab fixed dose of 1500 mg q4w for up to 12 months or until progression of disease unacceptable toxicity patients wish or investigators decision whichever comes first
After end of durvalumab therapy patients will undergo safety follow up for 90 7 days followed by survival follow up until overall end of study Overall end of study will be reached 24 months after the last patient has started durvalumab therapy Patients showing PD following chemoradiotherapy will be treated according to investigators decision but will be followed up until overall end of study
After end of durvalumab therapy patients will undergo safety follow up for 90 7 days followed by survival follow up until overall end of study Overall end of study will be reached 24 months after the last patient has started durvalumab therapy Patients showing PD following chemoradiotherapy will be treated according to investigators decision but will be followed up until overall end of study
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ARO 2023-06 | OTHER | ARO | None |
| 2022-003408-33 | EUDRACT_NUMBER | None | None |