NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

Official Title

Summary:

The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.

Trial Description

Primary Outcome:

Measurement of organ preservation rate

Secondary Outcome:

Locoregional Relapse Rate (LRR)
Distant Relapse Rate (DRR) estimated based on Kaplan-Meier method
Disease Free Survival (DFS) estimated based on Kaplan-Meier method
Rate of post-operative complications
Number and severity of adverse events using CTCAE V5
Quality of Life using QLQ-C30
Cost effectiveness using the EQ-5D-5L questionnaire

View this trial on ClinicalTrials.gov

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Resources

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