Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy (EGFR)

October 9, 2023 updated by: Esraa Ebrahim mohammed, Assiut University

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 .

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with left colon and rectum cancer of stage four received target therapy anti_EGFR targeted therapy

Description

Inclusion Criteria:

  1. age above 18
  2. Both sex
  3. Performance status zero to one according to ECOG scale system
  4. Histo-pathologial diagnosis adenocarcinoma of left colon or rectum.
  5. Patients diagnosed with left colon and rectal cancer.
  6. Patients eligible to receive chemotherapy (with renal and liver chemistry, and normal CBC.
  7. Patients diagnosed with metastatic stage.
  8. K-RAS wild type.

Exclusion Criteria:

  1. Second malignancy
  2. Histo-pathological types other than adenocarcinoma.
  3. Right colon cancer patients.
  4. Patients refused receiving anti_EGFR targeted therapy.
  5. Patients with any abnormalities preventing to receive chemotherapy.
  6. Early stages of colorectal cancer.
  7. K-RAS mutant type.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Anti_EGFR targeted therapy in assuit university hospitals from 2015 to 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Factors affecting response to targeted therapy
The response of patients to EGFR targeted therapy in AUH at period from 2015 to 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Samir E Shehata, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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