Colo-rectal CancerPhase 4NCT06843954
Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer
A Phase 4 study testing Bevacizumab in people with Colo-rectal Cancer, run by Mohammed Mahmood Mohammed at 1 site in Iraq.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2022to 30 Nov 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- The first group is the responder (Complete response and partial response)
- 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)
- Conditions
- Colo-rectal Cancer
- Being tested
- Bevacizumab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
bevacizumab (7.5mg/kg every 21 days) for minimum of 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab Group | Experimental | Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX) Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of Cycle 3 (each cycle is 21 days)
Secondary outcomes (2)
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.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Adverse effects (AE) rate
Asessment of any AE that occur during the study.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Sep 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX), at the end of the study NLR and PLR data were collected.
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Mahmood Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Mahmood Mohammed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843954
- Sponsor's protocol ID
- 106-38
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06843954
- Acronym / sponsor ID
- 106-38
- Conditions
- Colo-rectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Mohammed Mahmood MohammedUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Feb 2025 (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.
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.
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:
- The first group is the responder (Complete response and partial response)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX), at the end of the study NLR and PLR data were collected.
| Arm | Type | Receives |
|---|---|---|
| bevacizumab Group | Experimental | Drug: BevacizumabPatients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumabbevacizumab (7.5mg/kg every 21 days) for minimum of 3 cycles | Drug | bevacizumab Group |
Primary outcome
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
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
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)
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
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
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
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
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
2 secondary outcomes
Health related quality of life measure (HRQL)
Time frame: 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)
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 25 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab in people with Colo-rectal Cancer, run by Mohammed Mahmood Mohammed at 1 site in Iraq.
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 5 inclusion and 2 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complete response rate (CR) (time frame: At the end of Cycle 3 (each cycle is 21 days)). The study lists 8 primary outcomes in all. 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 25 Feb 2025.