Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT06083974

Collaborator

(none)

100

Enrollment

95.9

Actual Duration (Months)

Study Details

Study Description

Brief 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 .

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 .

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Adenocarcinoma

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

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Retrospective Study of Metastatic Left Colon and Rectal Cancer as Regard Treatment With Anti_EGFR Targeted Therapy

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 30, 2022

Actual Study Completion Date :

Dec 30, 2022

Outcome Measures

Primary Outcome Measures

OS and DFS of patients with metastatic colorectal cancer patients received anti_EGFR targeted therapy [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

Secondary Outcome Measures

Response rate (RR) in patients received chemotherapy only or with combination with targeted therapy. [The response of patients to EGFR targeted therapy in AUH at period from 2015 to 2022]
Factors affecting response to targeted therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Chair: Samir E Shehata, Professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Esraa Ebrahim mohammed, Principal investigator1, Assiut University

ClinicalTrials.gov Identifier:

NCT06083974

Other Study ID Numbers:

Anti_EGFR -Targeted therapy

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Esraa Ebrahim mohammed, Principal investigator1, Assiut University

EGFR, Targeted therapy ,metastatic colorectal cancer

Additional relevant MeSH terms:

Adenocarcinoma

Rectal Neoplasms

Study Results

No Results Posted as of Oct 16, 2023