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出境医 / 临床实验 / Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer

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

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

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
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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 1, 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017
Arms and Interventions
Group/Cohort
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.
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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Locations
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Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
SeongNam, GyeongGi, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
National Cancer Center, Korea
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jae-Hwan Oh, Ph.D. National Cancer Center, Korea
Principal Investigator: Kyu Joo Park, Ph.D. Seoul National University Hospital
Tracking Information
First Submitted Date April 16, 2019
First Posted Date April 22, 2019
Last Update Posted Date April 22, 2019
Actual Study Start Date May 1, 2016
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2019) 		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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer
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
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Rectal Cancer
  • Chemoradiation
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 19, 2019) 		142
Original Actual Enrollment Same as current
Actual Study Completion Date December 30, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03923309
Other Study ID Numbers B-1711/433-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The row data generated during and/or analysed during the current study couldn't be shared to public or other researcher because of institutional policy.
Responsible Party Sung-Bum Kang, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators
  • 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
PRS Account Seoul National University Hospital
Verification Date April 2019

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