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

NCT ID: NCT03923309

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer Chemoradiation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intended rectal preservation

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

No interventions assigned to this group

Unintended rectal preservation

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung-Bum Kang

Colorectal Surgeon, University Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Hwan Oh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Kyu Joo Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 27022115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28759121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27766558 (View on PubMed)

Other Identifiers

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B-1711/433-102

Identifier Type: -

Identifier Source: org_study_id

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