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Effect of Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer

Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer Patients as Predictive Factors for Systemic Therapy Outcome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04543019
Enrollment
50
Registered
2020-09-09
Start date
2020-12-31
Completion date
2022-09-30
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic

Brief summary

To determine progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer in relation to age, BMI and tumor sidedness, describing their predictive influence on systemic therapy outcome.

Detailed description

Colorectal cancer (CRC) represents a major public health concern as it is the third most frequently diagnosed cancer and the fourth cause of cancer-related mortality worldwide . The five-year survival rate is around 64.9% for all stages, while in metastatic cases, it only reaches 13.1% . Approximately 26% of CRCs are diagnosed at stage IV among patients aged younger than 50 years, compared with 23% in those aged 50 to 64 years and 19% among those aged 65 years and older. Overall survival (OS) among patients younger than 50 years (68%) is similar to that in those 50 to 64 years (69%) because of a later stage at diagnosis. Obesity is associated with an increased incidence of CRC . In recent studies body mass index (BMI) was prognostic for overall survival and progression free survival. That is risk of progression and/or death was greatest for low BMI; risk decreased as BMI increased. BMI was not predictive of treatment effect . Cachexia and associated poor performance status have previously been identified as negative prognostic factors in patients with CRC. Tumor sidedness is an independent prognostic factor in patients with early and metastatic CRC as left-sided primaries have improved outcomes. sidedness also represents a powerful predictor of benefit from anti epidermal growth factor receptor\[EGFR\] inhibitors therapies in patients with RAS wild-type metastatic CRC (mCRC) . The mainstay of treatment of mCRC includes cytotoxic chemotherapy with the addition of a molecularly targeted agent . The cytotoxic regimens that are usually used include a combination of oxaliplatin or irinotecan with a fluoropyrimidine, in addition to targeted agents such as \[EGFR\] inhibitors for patients with RAS wild-type mCRC or vascular endothelial growth factor inhibitors .

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age \>18 years. * Pathologically proven colon or rectal adenocarcinoma. * Stage IV colorectal cancer.

Exclusion criteria

* Age \<18 years. * Not pathologically proven colon or rectal adenocarcinoma. * Stage I, II and III colorectal cancer.

Design outcomes

Primary

MeasureTime frameDescription
Progression free survival (PFS) and overall survival (OS)between January 2015 and December 2019Progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer patients in correlation to age, BMI and tumor sidedness.

Secondary

MeasureTime frameDescription
response to systemic therapybetween January 2015 and December 2019response to systemic therapy in correlation to age, BMI and tumor sidedness

Contacts

Primary ContactGehad Abd el-razik, MD
dr.gehadahmed95@gmail.com01097381211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026