Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03838029
Status:
RECRUITING
Last Update Posted:
2019-11-20
First Post:
2019-01-23
Brief Title:
Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Perioperative Use of a Beta-adrenergic Blocker and a COX-2 Inhibitor in Patients Undergoing Surgery With Primary Pancreatic Cancer Intervention Aiming to Reduce Pro-metastatic Processes
Status:
RECRUITING
Status Verified Date:
2019-11
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:
BC-PC
Brief Summary:
In Israel of the 1000 patients diagnosed annually with pancreatic cancer PC approximately 250 25 percent will be eligible for curative surgery of which 80 percent will succumb to post-surgical metastatic disease A reduction in post-surgical metastatic disease will save dozens of patients in Israel annually and tens-of thousands-around the world The short perioperative period days to weeks around surgery is characterized by stress-inflammatory responses including catecholamines CAs eg adrenaline and prostaglandins PGs eg prostaglandin-E2 release and induce deleterious pro-metastatic effects Animal studies implicated excess perioperative release of CAs and PGs in facilitating cancer progression by affecting the malignant tissue its local environment and anti-metastatic immune functions Congruently our animal studies indicate that combined use of the beta-adrenergic blocker propranolol and the prostaglandins inhibitor etodolac - but neither drug separately - efficiently prevented post-operative metastatic development We recently conducted two clinical trials in three medical centers in Israel recruiting breast n38 and colorectal n34 cancer patients assessing the safety and short-term efficacy of perioperative propranolol and etodolac treatment Drugs were well tolerated without severe adverse events Importantly molecularbiological analyses of the excised primary tumor indicated that drug treatment caused promising anti-metastatic transformations as well as improvements in immune and inflammatory indices These included i decreased tumor cell capacity to migrate ii reduced pro-metastatic capacity of the malignant tissue and iii improvement in immune infiltrating into the tumor Paper published in Clinical Cancer Research 2017 Herein we propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 210 pancreatic cancer patients undergoing curative surgery in Israel A perioperative 35-day drug treatment will be initiated 5 days before surgery Primary outcomes will include i 1-year disease-free-survival DFS and 5-year overall survival OS and ii biological markers in blood samples and in the excised tumor tissue Secondary outcomes will include safety indices and psychological measures of depression anxiety distress and fatigue
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MOH_2018-03-12_002226 | REGISTRY | The Israeli Ministry of Health | None |