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

NCT03923309 | Completed

• 1 other identifier: B-1711/433-102
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 3

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.

Conditions

Rectal Cancer; Chemoradiation

Keywords

Organ preservation; Oncologic outcome

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival

  Overall survival rate at 3-year after completion of chemoradiotherapy

  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

Study Arms (2)

Intended rectal preservation

When rectal preservation (non-operative management or local excision) was agreed by their surgeon.

Unintended rectal preservation

When rectal preservation (non-operative management or local excision) was disagreed by their surgeon.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Cancer Center, Korea: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (3)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

• Ellis CT, Samuel CA, Stitzenberg KB. National Trends in Nonoperative Management of Rectal Adenocarcinoma. J Clin Oncol. 2016 May 10;34(14):1644-51. doi: 10.1200/JCO.2015.64.2066. Epub 2016 Mar 28.

  PMID: 27022115 BACKGROUND

• Cassidy RJ, Switchenko JM, Cheng E, Jiang R, Jhaveri J, Patel KR, Tanenbaum DG, Russell MC, Steuer CE, Gillespie TW, McDonald MW, Landry JC. Health care disparities among octogenarians and nonagenarians with stage II and III rectal cancer. Cancer. 2017 Nov 15;123(22):4325-4336. doi: 10.1002/cncr.30896. Epub 2017 Jul 31.

  PMID: 28759121 BACKGROUND

• Lee DY, Teng A, Pedersen RC, Tavangari FR, Attaluri V, McLemore EC, Stern SL, Bilchik AJ, Goldfarb MR. Racial and Socioeconomic Treatment Disparities in Adolescents and Young Adults with Stage II-III Rectal Cancer. Ann Surg Oncol. 2017 Feb;24(2):311-318. doi: 10.1245/s10434-016-5626-0. Epub 2016 Oct 20.

  PMID: 27766558 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jae-Hwan Oh, Ph.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

• Kyu Joo Park, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Surgeon, University Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 22, 2019
• Study Start: May 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)