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

Radboud University Medical Center1,431 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,431

Conditions

Rectal Neoplasms Neoplasm Recurrence, Local

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.)

Data from ClinicalTrials.gov

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