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

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 Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Drug: Capecitabine

• Study Type: Observational
• Enrollment (Actual): 161

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

all adult patients with newly diagnosed LARC with high risk factors for failure who were treated with TNT or standard therapy at the Institute of Oncology, Ljubljana, from 2016 to 2019

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
total neoadjuvant therapy; Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery.	Drug: Capecitabine; comparison of two treatments; Other Names: oxaliplatin
standard therapy; Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)	Drug: Capecitabine; comparison of two treatments; Other Names: oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological complete response	pathological complete response is defined as the absence of tumor cells in the surgical resection	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	during treatment, assessed up to 10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants who completed treatment	Compliance - number of participants who completed treatment protocol	during treatment, assessed up to 10 days
number of participants with acute side effects	Acute toxcity - number of participants with side effects during different treatment modality	during treatment, assessed up to 10 days

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: ERID-KSOPKR-0009/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes