DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: National Cancer Center, Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: Local excision (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Cancer Center, Korea

Official(s) and/or principal investigator(s):
Oh Jae Hwan, MD, PhD, Principal Investigator, Affiliation: National Cancer Center, Republic of Korea

Overall contact:
Oh Jae Hwan, MD, PhD, Phone: +821071047102, Email: jayoh@ncc.re.kr

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.

Clinical Details

Official title: Local Excision of Clinical T3 Mid- or Low-Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy: Prospective Multicenter Single-arm Phase II Clinical Trial

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 3-year disease free survival

Secondary outcome:

Complete response rate

Overall survival rate

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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Oh Jae Hwan, MD, PhD, Phone: +821071047102, Email: jayoh@ncc.re.kr

National Cancer Center, Goyang-si, Gyeonggi-do 410-769, Korea, Republic of; Recruiting
Oh Jae Hwan, MD, PhD, Phone: +8271047102, Email: jayoh@ncc.re.kr
Additional Information

Starting date: April 2015
Last updated: July 2, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017