Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367972
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-11
Brief Title:
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease EXTEND-OP
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease EXTEND-OP
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
To find out if local consolidation therapy such as radiation therapy with or without other local therapies such as surgery ablation the removal or destruction of a body part or tissue or its function or embolization a procedure that uses particles such as tiny gelatin sponges or beads to block a blood vessel to all progressive sites of disease can help to control the disease compared with next-line systemic therapy
Detailed Description:
Primary Objective
To determine whether in participants with oligoprogressive metastatic disease LCT to all progressive sites of disease offers a benefit in PFS compared to NLST across seven tumor types in a basket design
Secondary Objectives
To determine whether LCT improves OS in participants with oligoprogressive disease across seven tumor types
To assess safetytolerability of LCT in participants with oligometastatic disease in tumor subtypes
To compare quality of life QOL of LCT vs next-line systemic therapy in participants with oligoprogressive disease
To characterize duration and progression-free survival time of participants on same-line systemic therapy SLST after LCT in the experimental arm
To identify predictiveprognostic biomarkers correlated with a benefit for LCT across tumor types with the aim being to incorporate these biomarkers into future clinical trials
To determine whether in participants with oligoprogressive metastatic disease LCT to all progressive sites of disease offers a benefit in PFS compared to NLST across seven tumor types in a basket design
Secondary Objectives
To determine whether LCT improves OS in participants with oligoprogressive disease across seven tumor types
To assess safetytolerability of LCT in participants with oligometastatic disease in tumor subtypes
To compare quality of life QOL of LCT vs next-line systemic therapy in participants with oligoprogressive disease
To characterize duration and progression-free survival time of participants on same-line systemic therapy SLST after LCT in the experimental arm
To identify predictiveprognostic biomarkers correlated with a benefit for LCT across tumor types with the aim being to incorporate these biomarkers into future clinical trials
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 |
|---|---|---|---|
| NCI-2024-03278 | OTHER | NCI-CTRP Clinical Registry | None |