Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141070
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-13
Brief Title:
Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer NSCLC and Systemic Treatment With Systemic Treatment Alone
Status:
NOT_YET_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:
ANDROMEDA
Brief Summary:
This is a 21 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic 5 metastases NSCLC Stratification factors performance status gender and systemic strategy The systemic treatment consists of chemotherapychemoimmunotherapy or immunotherapy and is given according to local practice During the first 3 months of systemic treatment aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions Preferably with SBRT SRTSRS but conventional radiotherapy may also be used After the first three cycles of systemic treatment the patients are assessed and after four cycles they are continuing maintenance therapy if indicated The patients are followed with radiology every three months
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