Clinical trial NCT03923309: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Chemoradiation
Keywords: Organ preservation
Oncologic outcome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
name: Seoul National University Bundang Hospital
First posted: 2019-04-22
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: 3-year overall survival
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
city: SeongNam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: GyeongGi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: National Cancer Center, Korea
name: Jae-Hwan Oh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Kyu Joo Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.