Back to resultsCelecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colon Cancer Stage
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
FOLFERI
Folferi and celecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer Stage
Eligibility Criteria
Inclusion Criteria:
- advanced colorectal cancer
Exclusion Criteria:
- cerebral metastases
- other malignancy
- H pylori infection
- thromboembolism
Sites / Locations
- Amira RoushdyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FOLFERI
FOLFERI and celecoxib
Arm Description
FOLFERI regien
FOLFERI and celecoxib
Outcomes
Primary Outcome Measures
number of patients with improved radiology
number of patients with improved radiology
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03645187
Brief Title
Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title
Evaluation of Anticancer Effect of Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer
Detailed Description
The primary aim of the study is to evaluate the anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFERI
Arm Type
Active Comparator
Arm Description
FOLFERI regien
Arm Title
FOLFERI and celecoxib
Arm Type
Active Comparator
Arm Description
FOLFERI and celecoxib
Intervention Type
Drug
Intervention Name(s)
FOLFERI
Intervention Description
FOLFERI regimen
Intervention Type
Drug
Intervention Name(s)
Folferi and celecoxib
Intervention Description
Folferi regimen and celecoxib
Primary Outcome Measure Information:
Title
number of patients with improved radiology
Description
number of patients with improved radiology
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
advanced colorectal cancer
Exclusion Criteria:
cerebral metastases
other malignancy
H pylori infection
thromboembolism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek M Mostafa, Prof
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Alm El-din, prof
Organizational Affiliation
Clinical Oncology - Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amira Roushdy, Msc
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Study Director
Facility Information:
Facility Name
Amira Roushdy
City
Tanta
State/Province
Elgharbia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amira roushdy, msc
Phone
00201095159522
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35022282
Citation
Mostafa TM, Alm El-Din MA, Rashdan AR. Celecoxib as an adjuvant to chemotherapy for patients with metastatic colorectal cancer: A randomized controlled clinical study. Saudi Med J. 2022 Jan;43(1):37-44. doi: 10.15537/smj.2022.43.1.20210574.
Results Reference
derived
Learn more about this trial
Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
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