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

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ClinicalTrials.gov Identifier: NCT03548844
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Surgery Procedure: local excision Procedure: total mesorectal excision Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This trial is a a two-arm, open labelled, prospective, randomized phase III studies. Eligible patients with ypT0-1cN0 rectal cancer patients will be randomly assigned, in a 1:1 ratio, to receive either observation (local excision group) or complementary rectal excision (total mesorectal excision group).
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: local excision group
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group)
Procedure: local excision
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group) .

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




Primary Outcome Measures :
  1. DFS [ Time Frame: 3 years ]
    Disease-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 3 years ]
    Overall survival

  2. Morbidity rate [ Time Frame: 1 year ]
    Morbidity rate

  3. Mortality rate [ Time Frame: 1 year ]
    Mortality rate

  4. Anorectal function outcomes [ Time Frame: 3 years ]
    To evaluate defecating function with Wexner score

  5. Quality of life [ Time Frame: 3 years ]
    To evaluate quality of life with EORTC QLQ-30 questionnaire



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548844


Contacts
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Contact: Liang Kang, MD,PhD 008613602886833 eonkang@163.com

Locations
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China, Guangdong
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Liang Kang, MD, PhD    008613602886833    eonkang@163.com   
Sponsors and Collaborators
Yanhong Deng
Investigators
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Principal Investigator: Liang Kang, MD,PhD the Sixth Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Yanhong Deng, MD,PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03548844     History of Changes
Other Study ID Numbers: CRSSYSU01
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases