Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593431
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-31
Brief Title:
Extending Outcomes for Pancreas Cancer Patients with Nominal Oligometastatic Disease EXPAND a Randomized Phase III Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extending Outcomes for Pancreas Cancer Patients with Nominal Oligometastatic Disease EXPAND a Randomized Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The EXPAND trial EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma PDAC
Detailed Description:
Primary Objectives
To determine whether in patients with oligometastatic pancreatic ductal adenocarcinoma MDT to all sites of disease confers a benefit in PFS compared to systemic therapy alone
Secondary Objectives
Key secondary objective To determine whether in patients with oligometastatic pancreatic ductal adenocarcinoma MDT to all sites of disease confers a benefit in OS compared to systemic therapy alone
To assess safetytolerability of MDT in patients with oligometastatic PDAC
To assess time to new lesion formation between treatment arms
To assess time to next-line systemic therapy between treatment arms
To assess incidence and duration of time off systemic therapy between treatment arms
To assess incidence and duration of time on maintenance systemic therapy between treatment arms
To assess time to local failure between treatment arms for lesions present at enrollmentbaseline
To compare quality of life QOL between treatment arms
To assess the above primary and secondary objectives as well as exploratory objectives which may be differential based on receipt of different forms of MDT in the MDT arm eg surgery external beam radiotherapy etc
Exploratory Objectives
To identify predictiveprognostic biomarkers correlated with a benefit for MDT
To investigate changes in biomarker profile over time and in response to MDT
To determine whether in patients with oligometastatic pancreatic ductal adenocarcinoma MDT to all sites of disease confers a benefit in PFS compared to systemic therapy alone
Secondary Objectives
Key secondary objective To determine whether in patients with oligometastatic pancreatic ductal adenocarcinoma MDT to all sites of disease confers a benefit in OS compared to systemic therapy alone
To assess safetytolerability of MDT in patients with oligometastatic PDAC
To assess time to new lesion formation between treatment arms
To assess time to next-line systemic therapy between treatment arms
To assess incidence and duration of time off systemic therapy between treatment arms
To assess incidence and duration of time on maintenance systemic therapy between treatment arms
To assess time to local failure between treatment arms for lesions present at enrollmentbaseline
To compare quality of life QOL between treatment arms
To assess the above primary and secondary objectives as well as exploratory objectives which may be differential based on receipt of different forms of MDT in the MDT arm eg surgery external beam radiotherapy etc
Exploratory Objectives
To identify predictiveprognostic biomarkers correlated with a benefit for MDT
To investigate changes in biomarker profile over time and in response to MDT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None