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

September 14, 2020 updated by: Gehad Ahmed Abd El-Razik, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

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 .

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Total coverage sample will be used. Fifty patients having the inclusion criteria who presented to Clinical oncology department, Assiut university hospital between January 2015 to December 2019 will be included.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) and overall survival (OS)
Time Frame: between January 2015 and December 2019
Progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer patients in correlation to age, BMI and tumor sidedness.
between January 2015 and December 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response to systemic therapy
Time Frame: between January 2015 and December 2019
response to systemic therapy in correlation to age, BMI and tumor sidedness
between January 2015 and December 2019

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • systemic therapy in mCRC

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.

Subscribe