Metastatic Colorectal AdenocarcinomaEGFRNCT06083974
Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy
An observational study of Metastatic Colorectal Adenocarcinoma, run by Assiut University.
Trial summary
Colorectal cancer ranks the second lethal cancer and third prevalent malignant tumour worldwide, Despite of different odern modalities for diagnosis,large number of cases diagnosed at metastatic advanced stage . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Adenocarcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with left colon and rectum cancer of stage four received target therapy anti_EGFR targeted therapy
Who may be able to join
- age above 18
- Both sex
- Performance status zero to one according to ECOG scale system
- Histo-pathologial diagnosis adenocarcinoma of left colon or rectum.
- Patients diagnosed with left colon and rectal cancer.
- Patients eligible to receive chemotherapy (with renal and liver chemistry, and normal CBC.
- Patients diagnosed with metastatic stage.
- K-RAS wild type.
Who cannot join
- Second malignancy
- Histo-pathological types other than adenocarcinoma.
- Right colon cancer patients.
- Patients refused receiving anti_EGFR targeted therapy.
- Patients with any abnormalities preventing to receive chemotherapy.
- Early stages of colorectal cancer.
- K-RAS mutant type.
About this study
Official title: Retrospective Study of Metastatic Left Colon and Rectal Cancer as Regard Treatment With Anti_EGFR Targeted Therapy
Colorectal cancer ranks the second lethal cancer and third prevalent malignant tumour worldwide, Despite of different odern modalities for diagnosis,large number of cases diagnosed at metastatic advanced stage .
New treatment approach has been discovered habe been discovered making a huge revolution in metastatic colorectal cancer represented by targeted therapy including anti_EGFR ,anti_angiogenic and kinase inhibitors .
Read the detailed description
Retrospective study aims to evaluate the effect of EGFR expression in metastatic colorectal cancer and the outcome of treatment with anti_EGFR targeted therapy between left colon and rectal cancer
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Keywords
- EGFR, Targeted therapy ,metastatic colorectal cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
OS and DFS of patients with metastatic colorectal cancer patients received anti_EGFR targeted therapy
Evaluation of anti-EGFR targeted therapy on metastatic cancer rectum and left colon and factors affecting response to treatment
Measured: Anti_EGFR targeted therapy in assuit university hospitals from 2015 to 2022
Secondary outcomes (1)
Response rate (RR) in patients received chemotherapy only or with combination with targeted therapy.
Factors affecting response to targeted therapy
Measured: The response of patients to EGFR targeted therapy in AUH at period from 2015 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Jan 2015
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ebrahim mohammed, Assiut University
- Investigators
- Samir E Shehata, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083974
- Sponsor's protocol ID
- Anti_EGFR -Targeted therapy
- Acronym
- EGFR
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Metastatic Left Colon and Rectal Cancer as Regard Treatment With Anti_EGFR Targeted Therapy
- ClinicalTrials.gov ID
- NCT06083974
- Acronym / sponsor ID
- EGFR / Anti_EGFR -Targeted therapy
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Keywords
- EGFR, Targeted therapy ,metastatic colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer ranks the second lethal cancer and third prevalent malignant tumour worldwide, Despite of different odern modalities for diagnosis,large number of cases diagnosed at metastatic advanced stage .
New treatment approach has been discovered habe been discovered making a huge revolution in metastatic colorectal cancer represented by targeted therapy including anti_EGFR ,anti_angiogenic and kinase inhibitors .
Detailed description
Retrospective study aims to evaluate the effect of EGFR expression in metastatic colorectal cancer and the outcome of treatment with anti_EGFR targeted therapy between left colon and rectal cancer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with left colon and rectum cancer of stage four received target therapy anti_EGFR targeted therapy
Key inclusion criteria (8 listed)
- age above 18
- Both sex
- Performance status zero to one according to ECOG scale system
- Histo-pathologial diagnosis adenocarcinoma of left colon or rectum.
- Patients diagnosed with left colon and rectal cancer.
Key exclusion criteria (7 listed)
- Second malignancy
- Histo-pathological types other than adenocarcinoma.
- Right colon cancer patients.
- Patients refused receiving anti_EGFR targeted therapy.
- Patients with any abnormalities preventing to receive chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OS and DFS of patients with metastatic colorectal cancer patients received anti_EGFR targeted therapy
Time frame: Anti_EGFR targeted therapy in assuit university hospitals from 2015 to 2022
Evaluation of anti-EGFR targeted therapy on metastatic cancer rectum and left colon and factors affecting response to treatment
1 secondary outcome
Response rate (RR) in patients received chemotherapy only or with combination with targeted therapy.
Time frame: The response of patients to EGFR targeted therapy in AUH at period from 2015 to 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trialLink provided by the sponsor.
- Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal canceLink provided by the sponsor.
- tion between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in CancerLink provided by the sponsor.
- The biology of VEGF and its receptorLink provided by the sponsor.
- Advances and new perspectives in the treatment of metastatic colon cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir E Shehata, Professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Adenocarcinoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS and DFS of patients with metastatic colorectal cancer patients received anti_EGFR targeted therapy (time frame: Anti_EGFR targeted therapy in assuit university hospitals from 2015 to 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.