Celecoxib as Adjuvant Therapy to Chemotherapy in Patients... | NCT03645187

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

NCT03645187

Sponsor

Sherief Abd-Elsalam

Status

Unknown status

Last Update Posted

Apr 20, 2021Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Colon Cancer Stage

Interventions

FOLFERI
Folferi and celecoxib

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 22, 2018

First Submission Date that Met QC Criteria

Aug 22, 2018

First Posted Date

Aug 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2021

Last Update Posted Date

Apr 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFERI	Active Comparator	FOLFERI regien	Drug: FOLFERI
FOLFERI and celecoxib	Active Comparator	FOLFERI and celecoxib	Drug: Folferi and celecoxib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FOLFERI	Drug	FOLFERI regimen	FOLFERI
Folferi and celecoxib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with improved radiology	number of patients with improved radiology	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

advanced colorectal cancer

Exclusion Criteria:

cerebral metastases
other malignancy
H pylori infection
thromboembolism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, MD	Contact	00201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Tarek M Mostafa, Prof	Clinical pharmacy Department- Tanta University	Principal Investigator
Mohamed Alm El-din, prof	Clinical Oncology - Tanta University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amira Roushdy	Recruiting	Tanta	Elgharbia	35111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35022282	Derived	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.

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals