NCT02490709

Brief Summary

The purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

5 years

First QC Date

July 2, 2015

Last Update Submit

July 2, 2015

Conditions

Rectal Cancer

Keywords

Rectal neoplasmsColorectal neoplasmsLocal excision

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival

    Death or recurrence as an event

    1-5 years

Secondary Outcomes (2)

  • Complete response rate

    1-5 years

  • Overall survival rate

    1-5 years

Study Arms (1)

Local excision

EXPERIMENTAL

Local excision for rectal cancer with good response

Procedure: Local excision

Interventions

Local excisionPROCEDURE

Local excision for rectal cancer with good response

Local excision

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: more than 20 years
  • biopsy-proven adenocarcinoma of the rectum
  • clinical staging, cT3NxM0
  • Rectal cancer located 8 cm from the anal verge
  • Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0
  • ECOG performance status 2 or less

You may not qualify if:

  • Synchronous colon cancer or other malignancy
  • Obstructing rectal cancer
  • Pregnant or breast-feeding
  • Receiving any other study agents
  • History of prior colorectal cancer or inflammatory bowel disease
  • Hereditary colorectal cancer (FAP, HNPCC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsColorectal Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Oh Jae Hwan, MD, PhD

    National Cancer Center, Republic of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oh Jae Hwan, MD, PhD

CONTACT

+821071047102jayoh@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hospital

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 7, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

KR(1)