Short Running Head Obesity in Rectal Cancer Patients

NCT04759638 | Completed DMC

• 1 other identifier: 17KHCC42
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Oncology; Colorectal Cancer; Surgery; Surgical Oncology; Obesity

Outcome Measures

Primary Outcomes (2)

• Disease-Free Survival (DFS)

  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

  5 yers

• Overall Survival (OS)

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

  5 years

Secondary Outcomes (1)

• Pathological Complete Response (CR)

  5 years

Study Arms (1)

Rectal Cancer

Rectal Cancer

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

294 patients included in the study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

Location

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms; Colorectal Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Surgery

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: March 21, 2017
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)