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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645187
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 1, 2018
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arms and Interventions
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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
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Primary Outcome Measures :
  1. number of patients with improved radiology [ Time Frame: 6 months ]
    number of patients with improved radiology


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • advanced colorectal cancer

Exclusion Criteria:

  • cerebral metastases
  • other malignancy
  • H pylori infection
  • thromboembolism
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645187


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Amira Roushdy Recruiting
Tanta, Elgharbia, Egypt, 35111
Contact: amira roushdy, msc    00201095159522      
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03645187    
Other Study ID Numbers: celecoxib
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Celecoxib
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action