Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- Or Low-Rectal Cancer After Neoadjuvant Therapy

Surgery Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Of Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- or Low-Rectal Cancer After Neoadjuvant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03548844
• Other study ID #: CRSSYSU01
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: May 2023

Study information

• Verified date: May 2018
• Source: Sun Yat-sen University
• Contact: Liang Kang, MD,PhD
• Phone: 008613602886833
• Email: eonkang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with cT2-4aN0-2M0 mid- or low-rectal cancer received neoadjuvant chemotherapy or combined chemoradiotherapy. Good responders (cT0-1N0) patients received local excision 4-8 weeks after treatment. Pathologically verified ypT0-1 patients are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The composite end points include 3 year disease-free survival (DFS), overall survival (OS), recurrence, major morbidity and quality of life.

Description:

Total mesorectal excision is still the standard surgical treatment of mid-and low advanced rectal cancer after neoadjuvant treatment. This radical procedure inevitably has the risk of major short and long term morbidity and anorectal function impairment. Additionally, abdominal perineal resection(APR) with permanent stoma is still applied to some low rectal cancer patients, even though major response had been achieved after neoadjuvant treatment. Previous studies have proposed "wait and see" strategy in clinical complete response patients. The local recurrence rate is still high due to residue adenocarcinoma lesion.

Local excision is a conservative alternative approach associated with low mortality and morbidity and high quality of life. In this study, the investigators proposed local excision in good responders (cT0-1N0) 4-8 weeks after neoadjuvant treatment. Patients with pathologically verified complete response (ypT0-1cN0) are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The purpose of this prospective randomized controlled study is to compare local excision versus total mesorectal excision in pathological complete response (ypT0-1cN0) mid- or low-rectal cancer after neoadjuvant therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: May 2023
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1?Willing and able to provide written informed consent. 2?Histological or cytological documentation of adenocarcinoma of the rectum (=8 cm from the anal verge).

3?ypT0-1cN0 after neoadjuvant therapy 4?No metastatic disease. 5?Patient is at least 18 years of age. 6?Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7?Non complicated primary tumor (obstruction, perforation, bleeding).

Exclusion Criteria:

• 1?T1, T4 tumour or anal sphincter invasion 2?Metastatic disease (M1) 3?Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy 4?Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study 5?History of cancer

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

Procedure:
• local excision
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group) .
• total mesorectal excision
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to complementary rectal excision (total mesorectal excision group).

Locations

Country	Name	City	State
China	Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yanhong Deng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	Disease-free survival	3 years
Secondary	OS	Overall survival	3 years
Secondary	Morbidity rate	Morbidity rate	1 year
Secondary	Mortality rate	Mortality rate	1 year
Secondary	Anorectal function outcomes	To evaluate defecating function with Wexner score	3 years
Secondary	Quality of life	To evaluate quality of life with EORTC QLQ-30 questionnaire	3 years