Local Excision of Clinical T3 Rectal Adenocarcinoma Showi... | NCT02490709

Studies
Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy

NCT02490709

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jul 7, 2015Estimated

Enrollment

86Estimated

Phase

Phase 2

Conditions

Rectal Cancer

Interventions

Local excision

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2020Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2015

Last Update Posted Date

Jul 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jae Hwan Oh, Director, Hospital, National Cancer Center, KoreaPrincipal Investigator

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is a prospective multicenter single-arm phase II clinical trial. Rectal cancer patients with cT3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. For those who have good response (ycT0-1) will underwent transanal local excision under the patients' agree.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Local excision	Experimental	Local excision for rectal cancer with good response	Procedure: Local excision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Local excision	Procedure	Local excision for rectal cancer with good response	Local excision

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year disease free survival	Death or recurrence as an event	1-5 years

Secondary Outcomes

Measure	Description	Time Frame
Complete response rate	The rate of complete response of the tumor after neoadjuvant chemoradiotherapy	1-5 years
Overall survival rate	Death as an event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oh Jae Hwan, MD, PhD	Contact	+821071047102		jayoh@ncc.re.kr

Overall Officials

Name	Affiliation	Role
Oh Jae Hwan, MD, PhD	National Cancer Center, Republic of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center	Recruiting	Goyang-si	Gyeonggi-do	410-769	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015412	Mastectomy, Segmental

Ancestor Terms

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided