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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03923309

Recruitment Status Completed

First Posted April 22, 2019

Last update posted April 22, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Rectal Cancer
    Chemoradiation
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 142 participants
  • Observational Model: Case-Control
  • Time Perspective: Retrospective
  • Official 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
  • Actual Study Start Date: May 2016
  • Actual Primary Completion Date: December 2017
  • Actual Study Completion Date: December 2017
Outcome Measures
  • Primary Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Intended organ preservation - non-operative management or local excision selected by surgeon Unintended organ preservation - non-operative management or local excision persisted by patient and disagreed by surgeon
Criteria

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

Contacts and Locations
Contacts
Locations

Korea, Republic of, Gyeonggi-do
National Cancer Center, Korea
Goyang-si

Korea, Republic of, GyeongGi
Seoul National University Bundang Hospital
SeongNam

Korea, Republic of
Seoul National University Hospital
Seoul

Sponsors and Collaborators

Seoul National University Hospital

National Cancer Center, Korea

Seoul National University Bundang Hospital

Investigators

Principal Investigator: Jae-Hwan Oh, Ph.D. National Cancer Center, Korea

Principal Investigator: Kyu Joo Park, Ph.D. Seoul National University Hospital

More Information