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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923309
• Other study ID #: B-1711/433-102
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiation
• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	GyeongGi
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Cancer Center, Korea, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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