Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer

Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer: a Retrospective, Population-based Cohort Study

Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms; Neoplasm Recurrence, Local

• Study Type: Observational
• Enrollment (Actual): 1431

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with stage I-III primary rectal cancer in the first half of 2015.

Description

Inclusion Criteria:

• Histologically confirmed stage I-III primary rectal carcinoma;
• Diagnosed between January 1st and June 30th of 2015;
• TME resection of primary rectal carcinoma.

Exclusion Criteria:

• Neuroendocrine tumor morphology;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients	UNIT OF MEASUREMENT: Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients MEASUREMENT TOOL: Registration of diagnosis of locally recurrent rectal cancer in the electronic patient file. The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locally recurrent rectal cancer at that time point.	Three years
Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients	UNIT OF MEASUREMENT: Risk factors for development of locally recurrent rectal cancer in primary rectal cancer patients MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary rectal cancer in the electronic patient file and national pathological database (PALGA). Clinical and pathological risk factors for the development of locally recurrent rectal cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locally recurrent rectal cancer.	Three years
Proportions of treatment given to patients with locally recurrent rectal cancer	UNIT OF MEASUREMENT: Proportions of treatment given to patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of treatment for locally recurrent rectal cancer in the electronic patient file. Using descriptive statistics, treatment patterns of patients with locally recurrent rectal cancer will be identified. Groups that will be created, will also be used to assess overall survival.	Three years
Overall survival of patients with locally recurrent rectal cancer	UNIT OF MEASUREMENT: Overall survival of patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database. Overall survival will be estimated for patients with locally recurrent rectal cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)	Three years

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): June 30, 2015

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasms; Recurrence; Rectal Neoplasms; Neoplasm Recurrence, Local
• Other Study ID Numbers: K20.256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be requested through the Netherlands Cancer Registry.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No