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

Official Title

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

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

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society