Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03959150
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2019-05-18
Brief Title:
Metronomic Chemotherapy With Capecitabine for Pancreatic Cancer
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Multi-center II PhaseRandomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Gemcitabine Plus Capecitabine Standard Adjuvant Therapy for Stage IIIII Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
The latest guidelines recommend Gemcitabine plus Capecitabine as the first choice of adjuvant chemotherapy for pancreatic cancer patients in good physical condition In order to prolong the survival of patients and improve the cure rate metronomic chemotherapy with capecitabine is a safe effective and economical treatment mode after adjuvant chemotherapy This study is trying to determine that compared with observation group if capecitabine metronomic medication is a better choice after adjuvant chemotherapy
Detailed Description:
Capecitabine Xeloda is currently the most biologically active oral fluoropyrimidine drug and is widely used in adjuvant therapy for pancreatic cancer It is usually taken twice a day in the morning and in the evening for 2 weeks followed by a 1 week break before repeating the next dosage cycle In this study capecitabine will be prescribed as dosage of 500mgm2 and maintain for a whole year after the standard treatment in stage IIIII pancreatic cancer patients 1 year disease-free survival is set as the primary outcome OS RFS AEs and exploratory biomarkers including effects of metronome chemotherapy on immune cells such as NK cells T cells TAMs B cells etc are also observed as the secondary outcomes Statistical analysis are made to see compared with observation group whether this metronomic therapy of capecitabine 500mgm2 will bring benefit to pancreatic cancer patients
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