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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
157
bevacizumab (7.5mg/kg every 21 days) for minimum of 3 cycles
Baghdad Medical city
Baghdad, Iraq
Complete response rate (CR)
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
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Partial Response rate (PR)
No less than of 30% reduction in the intended lesion sum diameters, using use the baseline sum diameters as a guide
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Progressive Disease rate (PD)
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)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Stable Disease rate (SD)
There is neither enough rise nor enough reduction to be acceptable as PR or PD, using the lowest total diameters as a reference
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Overall survival (OS)
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
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Progression free survival (PFS)
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
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Objective Response Rate (ORR)
It is the proportion of participants in a therapy group that, within a particular period of time, respond completely or partially to the treatment
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Disease control rate (DCR)
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
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Health related quality of life measure (HRQL)
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.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Adverse effects (AE) rate
Asessment of any AE that occur during the study.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
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