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OpenTrials
Completed

NCT Number: NCT04759638

Short Running Head Obesity in Rectal Cancer Patients

There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.

The obesity paradox appears to exist in rectal cancer patients treated with nCRT and surgery, as it was associated with significantly higher rates of pathological complete response and R0 resection.

Underweight patients were at higher risk for anastomotic leak and R1 resection.

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Key information

About this study

Background:

Obesity and underweight are associated with increased risk of postoperative morbidity in colorectal cancer patients undergoing surgery. There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.

Objective:

The aim of this study was to evaluate the effect of BMI on short- and long-term oncological outcomes as well as postoperative complications in rectal cancer patients who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery.

Setting:

Tertiary Cancer Center serving pediatric and adult patients in Jordan and the Middle East.

Patients:

The medical records of patients with stage II-III rectal cancer who received nCRT followed by surgery during 2006 to 2018 were retrospectively reviewed. The patients were subdivided according to their BMI into less than 20 kg/m2 defined as underweight; between 20 to 30 kg/m2 defined as normal range weight, above 30 kg/m2 defined as obese.

Main Outcome Measures:

Disease-Free Survival (DFS), Overall Survival, Pathological Complete Response (CR)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent rectal surgery at King Hussein Cancer Center (KHCC) from 2006 to 2018 were identified. Those with locally advanced rectal cancer (stages II and III) who underwent nCRT followed by surgery with curative intent were included.

Exclusion criteria

  • Patients with early rectal cancer (stage I) who did not require nCRT and those who underwent rectal surgery as part of a staged or simultaneous approach for metastatic disease (stage IV) were excluded.

Treatment and study plan

Primary outcomes

  1. Disease-Free Survival (DFS)

    Time frame: 5 yers

    Disease-free survival (DFS) was defined as the time from surgical resection to disease recurrence (including loco-regional failure or metastases) or death of any cause

  2. Overall Survival (OS)

    Time frame: 5 years

    Overall survival (OS) was defined as the time interval from surgical resection to either death from any cause or last follow up

Secondary outcomes

  1. Pathological Complete Response (CR)

    Time frame: 5 years

    Pathological CR was defined as no viable cancer cells in the excised specimen.

Sponsors and collaborators

Lead sponsor

King Hussein Cancer Center

Other

Registry information

Official study title

Body Mass Index Role in the Oncological Outcome of Locally Advanced Rectal Cancer: The Two BMI Extremes as Comparative Groups, A Retrospective Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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