Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer

February 22, 2025 updated by: Mohammed Mahmood Mohammed
This study will be a prospective one conducted within a time frame between September 2022 and April 2023. One hundred adult patients already diagnosed with CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Three to six cycles will be given, and to explore the response to treatment, the Response Evaluation Criteria in Solid Tumors (RECIST) will be used to assess the response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective one conducted within a time frame between September 2022 and April 2023. One hundred adult patients already diagnosed with CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Three to six cycles will be given, and to explore the response to treatment, the Response Evaluation Criteria in Solid Tumors (RECIST) will be used to assess the response. It is a standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger after there must be at least one tumor that can be measured by CT scans, MRI scans, or PET scan (every 8-12 weeks)where "Complete response" (CR) defined as the disappearance of all tumor lesions, "partial response" (PR) as a reduction of > 30% and they will be stable disease" (SD) as a reduction of < 30% or a growth of < 20% and "progressive disease" (PD) as growth of > 20% or the occurrence of new lesions; all changes will be relative to the baseline imaging. Non-responders are patients with stable disease (SD) or progressive disease (PD). Patients will be separated into three groups:

  1. The first group is the responder (Complete response and partial response)
  2. The second group is the no responder (progressive disease and stable disease) To explore the association between SNPs and BEV treatments, we will explore the association of VEGFA polymorphisms with BEV's therapeutic efficacy in CRC patients. ORR, DCR, and PFS will estimate the results.

ORR is the Objective response rate Percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment. Disease Control Rate (DCR) is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to therapeutic intervention in clinical trials of anticancer agents, and PFS (progression-free survival is defined as the interval from the date on which treatment with bevacizumab was initiated to tumor progression)

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq, 10001
        • Baghdad Medical city

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

Description

Inclusion Criteria:

  • All eligible patients will be age over 18 years old. The risk of colorectal cancer increases with age; 90% of cases are diagnosed in individuals 50 years of age and older.
  • Most patients had a performance status (WHO = 0-2), which is a score that estimates the patient's ability to perform certain activities of daily living (ADLs) without the help of others. Performance status (PS) is one of the strongest prognostic factors for survival in metastatic colorectal cancer patients.
  • In all cases, the initial tumor site will be the colon.
  • Adult patients already diagnosed with metastatic CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI).
  • Chronic disease patients will be involved

Exclusion Criteria:

  • Patient received bevacizumab and chemotherapy for inadequate cycles; the adequate cycle should be not less than three cycle
  • Patients participating in the study and not receive bevacizumab owing to risk factors for serious adverse events like GI perforation, Wounds that don't heal, Serious bleeding, Severe high blood pressure

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab Group
Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX)
Drug: Bevacizumab
bevacizumab (7.5mg/kg every 21 days) for minimum of 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CR)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
Every target lesion disappears. Any troublesome lymph nodes, whether they are target or non-target, need to have at least 10 mm removed from their short axis
At the end of Cycle 3 (each cycle is 21 days)
Partial Response rate (PR)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
No less than of 30% reduction in the intended lesion sum diameters, using use the baseline sum diameters as a guide
At the end of Cycle 3 (each cycle is 21 days)
Progressive Disease rate (PD)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
Target lesions' total diameters should rise by at least 20%, applying the smallest overall diameters serving as a guide. (Note: the emergence of one or more additional lesions is likewise regarded as progression)
At the end of Cycle 3 (each cycle is 21 days)
Stable Disease rate (SD)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
There is neither enough rise nor enough reduction to be acceptable as PR or PD, using the lowest total diameters as a reference
At the end of Cycle 3 (each cycle is 21 days)
Overall survival (OS)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
The duration by months from chance to death for all patients who received Bevacizumab was calculated additionally, we excluded any patients who were still alive or lost to follow-up at the time of assessment
At the end of Cycle 3 (each cycle is 21 days)
Progression free survival (PFS)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
The number of months, for all patients alive at the time of assessment from selection of patients until the first sign of disease advancement or death
At the end of Cycle 3 (each cycle is 21 days)
Objective Response Rate (ORR)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
It is the proportion of participants in a therapy group that, within a particular period of time, respond completely or partially to the treatment
At the end of Cycle 3 (each cycle is 21 days)
Disease control rate (DCR)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
The percent (%) of patients with advanced cancer who have seen a full response, only partial response, or stable illness as a result of their therapeutic intervention
At the end of Cycle 3 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life measure (HRQL)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
It is a crucial measure that shows clinical benefit and is patient-reported. It is an assessment of a patient's QOL in relation to their health over an extended period of time. The QLQ-C30 version 3.0 tool, developed by the "European -Organization -for Research and Treatment of Cancer" (EORTC), is used to evaluate how colorectal cancer affects a person's QOL. This survey was approved straight from the EORTC Data Centre in Belgium after it was translated and verified in a number of languages, including Arabic language.
At the end of Cycle 3 (each cycle is 21 days)
Adverse effects (AE) rate
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
Asessment of any AE that occur during the study.
At the end of Cycle 3 (each cycle is 21 days)

Collaborators and Investigators

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

Sponsor

Mohammed Mahmood Mohammed

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)

September 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-38

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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