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

NCT ID: NCT03645187

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2025-12-31

Brief Summary

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The study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Detailed Description

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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

Conditions

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Colon Cancer Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFERI

FOLFERI regien

Group Type ACTIVE_COMPARATOR

FOLFERI

Intervention Type DRUG

FOLFERI regimen

FOLFERI and celecoxib

FOLFERI and celecoxib

Group Type ACTIVE_COMPARATOR

Folferi and celecoxib

Intervention Type DRUG

Folferi regimen and celecoxib

Interventions

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FOLFERI

FOLFERI regimen

Intervention Type DRUG

Folferi and celecoxib

Folferi regimen and celecoxib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* advanced colorectal cancer

Exclusion Criteria

* cerebral metastases
* other malignancy
* H pylori infection
* thromboembolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

PhDTropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tarek M Mostafa, Prof

Role: PRINCIPAL_INVESTIGATOR

Clinical pharmacy Department- Tanta University

Mohamed Alm El-din, prof

Role: STUDY_DIRECTOR

Clinical Oncology - Tanta University

Amira Roushdy, Msc

Role: STUDY_DIRECTOR

Clinical pharmacy Department- Tanta University

Locations

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Amira Roushdy

Tanta, Elgharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, MD

Role: CONTACT

00201147773440

Facility Contacts

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amira roushdy, msc

Role: primary

00201095159522

References

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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.

Reference Type DERIVED
PMID: 35022282 (View on PubMed)

Other Identifiers

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celecoxib

Identifier Type: -

Identifier Source: org_study_id

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