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

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ClinicalTrials.gov Identifier: NCT03645187
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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: FOLFOX Drug: Folfox 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

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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

Arm Intervention/treatment
Active Comparator: FOLFOX
FOLFOX regien
Drug: FOLFOX
FOLFOX regimen

Active Comparator: Folfox and celecoxib
Folfox and celecoxib
Drug: Folfox and celecoxib
Folfox regimen and celecoxib




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



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

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

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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03645187     History of Changes
Other Study ID Numbers: celecoxib
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Leucovorin
Celecoxib
Fluorouracil
Oxaliplatin
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
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents