Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815927
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-03-13
Brief Title:
Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Pembrolizumab and Radiotherapy for OLigometastatic Squamous Cell Carcinoma of the Head and Neck a Randomized Phase III Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
PROLoNg
Brief Summary:
This is a randomized open-label multicentre phase III superiority study of the effect of adding SABR to the standard of care treatment pembrolizumab on progression free survival in patients with oligometastases of a squamous cell carcinoma of the head and neck SCCHN histological confirmation of the primary disease at first diagnosis and PD-L1 CPS 1 After eligibility check and signing informed consent all patients will be prospectively enrolled in a 11 ratio between current standard of care treatment pembrolizumab Arm 1 vs SABR standard of care treatment Arm 2 to oligometastases
Any radical treatment to the synchronous primary recurrent primary tumor andor involved cervical nodes surgery or radiotherapy as decided by the local tumor board treating physicians should be completed prior to enrolmentSurgical removal of metastases is allowed for diagnostic purposes or for brain metastases as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR Such surgical procedures should be performed prior to enrolment
Any radical treatment to the synchronous primary recurrent primary tumor andor involved cervical nodes surgery or radiotherapy as decided by the local tumor board treating physicians should be completed prior to enrolmentSurgical removal of metastases is allowed for diagnostic purposes or for brain metastases as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR Such surgical procedures should be performed prior to enrolment
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 |
|---|---|---|---|
| 2023-504478-39-00 | OTHER | EU trial number | None |