Comparison between local excision and radical excision in mid-to-low rectal cancer patients who revealed good response after preoperative chemoradiotherapy

Verification of local excision in mid-to-low rectal cancer patients who revealed clinically total or near-total regression after preoperative chemoradiotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002579

Enrollment

140

Registered

2017-12-01

Start date

2017-03-29

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Local excision will bee performed through all kind of transanal approach including transanal excision and transanal minimal invasive surgery. Radical excision includes open, laparo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -pathologically-proven adenocarcinoma below 8 cm from the anal verge -mrTRG 1 (radiologically complete remission) or mrTRG 2 (radiologically near-complete remission, only remained fibrosis) after Preoperative chemoradiotherapy and confirmed by multi-disciplinary team or central adjudification. -more than 20 years-old and below 80 years-old -Good performance status (ECOG performance status 2 or less) -agreed with this study

Exclusion criteria

Exclusion criteria: -pathologically-proven adenocarcinoma above 8 cm from the anal verge -microperforated tumor before preoperative chemoradiotherapy -previous history of radiotherapy -presence of distant metastasis, other malignancies, or synchronous colorectal cancer -history of treatment for other malignancies -included other study related to surgical method -pregnancy or feeding

Design outcomes

Primary

Measure	Time frame
Postoperative complication rate	—

Secondary

Measure	Time frame
recurrence rate and survival rate; quality of life including defecatory function;Accuracy of mrTRG (tumor regression) comapred with pathologic TRG;Analysis of effectiveness between local excision and total mesorectal excision	—

Countries

Korea, Republic of

Contacts

Public ContactJONG LYUL LEE

Asan Medical Center

iamleejong@hotmail.com+82-2-3010-1732

Outcome results