ClinicalTrials.gg
RecruitingNCT03645187Updated Apr 20, 2021

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

A Phase 4 interventional study of FOLFERI and Folferi and celecoxib in Colon Cancer Stage, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Sherief Abd-Elsalam · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2018; still recruiting 8 years 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies in Colonic Neoplasms with a site in Egypt — 5 open to participants now, 5 under way, none of them phase 3. Colonic Neoplasms · Egypt.

Planned enrollment
18th of 30
50 · median 60
Started
2018
with 2 others
Phase 4
2 of 37
1 open now
Registered
9th of 37
by date
Lead sponsor
2 of 37
Sherief Abd-Elsalam

Among the 37 studies in Colonic Neoplasms with a site in Egypt, this one is the 18th largest by planned enrollment of the 30 interventional ones, is one of 3 that started in 2018, is one of 2 in phase 4, and was the 9th registered.

By phase

37 studies; the count open now beside each. This study's row is marked.

No phase17 · 3 open
Observational6 · 0 open
Phase 35 · 0 open
Phase 13 · 0 open
Phase 22 · 1 open
Phase 4this study2 · 1 open
Phase 1/21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1999; this study’s year is marked. 3 started in 2018.

Size and results

Median enrollment 60 across the 30 interventional studies, 60 across the 6 observational. Of the 23 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 37 studies in Colonic Neoplasms with a site in Egypt, or all of them as a file.
02

Study summary

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

Read the 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

03

Conditions studied

  • Colon Cancer Stage

Browse trials for

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • advanced colorectal cancer

Exclusion criteria

Exclusion Criteria:

  • cerebral
  • other
  • H pylori infection
  • thromboembolism
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    FOLFERI

    FOLFERI regien

    Drug: FOLFERI

  • Active comparator
    FOLFERI and celecoxib

    FOLFERI and celecoxib

    Drug: Folferi and celecoxib

Interventions

  • DrugFOLFERI

    FOLFERI regimen

  • DrugFolferi and celecoxib

    Folferi regimen and celecoxib

06

What researchers measure

Primary outcomes

  1. number of patients with improved radiology

    number of patients with improved radiology

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Amira Roushdy
    Tanta, Elgharbia 35111, Egypt
    Recruiting
    • amira roushdy, msc · Contact00201095159522
08

References and documents

Publications

  • 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. PubMed 35022282 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2018 (actual). Primary completion is estimated for Aug 2025, 84 months after the start.

Of 16 phase 4 interventional studies under Colonic Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 105. This study's planned 84 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2018
First posted
Aug 24, 2018
StartActual
Aug 1, 2018
Primary completionEst.
Aug 2025
CompletionEst.
Dec 2025
Last update
Apr 20, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03645187
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (PhDTropical Medicine, Tanta University) — Sponsor-investigator
First posted
Aug 24, 2018
Start date
Aug 1, 2018
Primary completion
Aug 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Apr 20, 2021

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Tarek M Mostafa, Prof
principal investigator · Clinical pharmacy Department- Tanta University
Mohamed Alm El-din, prof
study director · Clinical Oncology - Tanta University
Amira Roushdy, Msc
study director · Clinical pharmacy Department- Tanta University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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