Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure

Institute of Oncology Ljubljana161 enrolled

Overview

In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.

Study Type

OBSERVATIONAL

Enrollment

161

Conditions

Rectal Cancer

Interventions

CapecitabineDRUG

comparison of two treatments

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * histologically proven locally advanced rectal cancer and * the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node. Exclusion Criteria: * distant metastases, * concomitant malignancy, * inflammatory bowel disease, or * malabsorption syndrome.

Outcomes

Primary Outcomes

pathological complete response

pathological complete response is defined as the absence of tumor cells in the surgical resection

Time frame: during surgery

Secondary Outcomes

Neoadjuvant rectal cancer score

Neoadjuvant rectal cancer score: The NAR score was calculated using the equation \[5 pN - 3(cT - pT) + 12\]\^2 / 9.61 and further classified as low (\< 8), intermediate (8-16), or high (\< 16).

Time frame: during treatment, assessed up to 10 days

Data from ClinicalTrials.gov

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