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

Completed

• Conditions: Chemoradiation; Rectal Cancer

• Registration Number: NCT03923309
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2016-05-01
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2019-04
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Study First Posted: 2019-04-22
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year overall survival	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

Trial Locations

Locations (3)

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, Korea, Republic of