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NCT Number: NCT03923309

Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer

Though refusal of radical surgery was often happened in rectal cancer patient after neoadjuvant chemoradiotherapy, little is currently known about the actual oncologic outcome of it. Thus the investigators designed this study to compare the oncologic outcome of unintended rectal preservation with intended rectal preservation by surgeon.

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Key information

Conditions

Rectal Cancer Chemoradiation Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center, Korea, Goyang-si, Gyeonggi-do, South Korea

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About this study

The investigators identified patients whose organ were preserved by non-operative management or local excision after neoadjuvant chemoradiotherapy for mid to low rectal cancer. Then, the patients were categorized into two groups according to the agreement on omitting radical surgery (rectal preservation). When treatment decision was agreed by their surgeon, the patients were categorized as intended rectal preservation. When there was disagreement by surgeon on rectal preservation, then the patients categorized as unintended rectal preservation. Oncologic outcome was compared between two groups.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • biopsy proven rectal cancer (anal verge ≤ 10cm)
  • neoadjuvant radiotherapy or chemoradiotherapy
  • no radical surgery after neoadjuvant therapy

Exclusion criteria

  • other malignant disease
  • other fatel disease
  • incompletion of half of radiotherapy course
  • metastasis on initial presentation

Treatment and study plan

Primary outcomes

  1. 3-year overall survival

    Time frame: from date of completion of chemoradiotherapy until the date of death from any cause, whichever came first, assessed at 31th December 2017 by checking expire date of a resident registration number

    Overall survival rate at 3-year after completion of chemoradiotherapy

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Cancer Center, Korea
  • Seoul National University Bundang Hospital

Registry information

Official study title

Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer: a Multicenter Comparative Study With Rectal Preservation as Supported by Surgeon

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2019
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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