Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer

• Sponsor: Sherief Abd-Elsalam (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03645187
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 88
• Patients Per Site Per Month: 0.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Stage	Drug: FOLFERI; Drug: Folferi and celecoxib	Phase 4

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Anticancer Effect of Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
• Actual Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FOLFERI FOLFERI regien	Drug: FOLFERI; FOLFERI regimen
Active Comparator: FOLFERI and celecoxib FOLFERI and celecoxib	Drug: Folferi and celecoxib; Folferi regimen and celecoxib

Outcome Measures

Primary Outcome Measures

1. number of patients with improved radiology [6 months]

   number of patients with improved radiology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• advanced colorectal cancer

Exclusion Criteria:

• cerebral metastases

• other malignancy

• H pylori infection

• thromboembolism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amira Roushdy	Tanta	Elgharbia	Egypt	35111

Sponsors and Collaborators

• Sherief Abd-Elsalam

Investigators

• Principal Investigator: Tarek M Mostafa, Prof, Clinical pharmacy Department- Tanta University
• Study Director: Mohamed Alm El-din, prof, Clinical Oncology - Tanta University
• Study Director: Amira Roushdy, Msc, Clinical pharmacy Department- Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT03645187
• Other Study ID Numbers: celecoxib
• First Posted: Aug 24, 2018
• Last Update Posted: Apr 20, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Colorectal Neoplasms; Celecoxib

Study Results

No Results Posted as of Apr 20, 2021