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Simple Transanal Local Excision,Transanal Local Excision Following Radiotherapy Versus Total Mesorectum Excision for the Treatment of the Ultra-low T2N0M0 Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04098471
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision,transanal local excision following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: transanal local excision following radiotherapy Not Applicable

Detailed Description:

Rectal cancer is one of the most common malignancy worldwide. Currently, surgery is the main treatment for stage I rectal cancer, which has good therapeutic effect. For ultra-low rectal cancer, transanal local excision (TLE) has many advantages over total mesorectal excision (TME), such as less trauma, shorter hospitalization time, lower incidence of complications, protection of sexual function and protection of anal function. At present, transanal local excision has become the recommended operation for the T1N0M0 rectal cancer. However, the risk of lymph node metastasis still occurs in stage I tumors, especially in stage T2 tumors, the lymph node metastasis rate can reach 12% - 29% according to the literature. Salvage TME or chemoradiotherapy should be considered for the presence of positive margin of incision, lymphatic/vascular invasion and poor histological differentiation after transanal local excision. At present, the investigators have consulted a large number of literatures and found that TEM is still lack of sufficient evidence in the treatment of T2N0M0 ultra-low rectal cancer. Some studies believed that local excision combined with adjuvant therapy is safe and reliable, but the evidence is not enough. For ultra-low T2N0M0 rectal cancer, more studies need to be carried out to provide guidance for clinical treatment.

In this study, eligible patients will be randomly allocated to operative operation for rectal cancer either by simple TLE,TLE following radiotherapy or TME. 5-years disease free survival rate, 5-years overall survival rate,local recurrence rate and postoperative quality of life will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial to Investigate the Effects of Transanal Local Excision Following Radiotherapy for the Treatment of Ultra-low T2N0M0 Rectal Cancer
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Experimental: single transanal loca excision Procedure: transanal local excision following radiotherapy
transanal local excision following radiotherapy

Experimental: transanal local excision following radiotherapy Procedure: transanal local excision following radiotherapy
transanal local excision following radiotherapy

Experimental: total mesorectal excision Procedure: transanal local excision following radiotherapy
transanal local excision following radiotherapy

Primary Outcome Measures :
  1. 5-years disease free survival rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 5-years overall survival rate [ Time Frame: 5 years ]
  2. local recurrance rate [ Time Frame: 5 years ]
  3. operative time [ Time Frame: 1 day ]
  4. hospitalization time [ Time Frame: 15 days ]
  5. postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Preoperative pathology confirmed adenocarcinoma.
  2. Preoperative MRI or digital examination of tectum confirmed that the distances from the lower edge of the tumors to the anus were less than 5 cm.
  3. The mass is not fixed.
  4. Preoperative MRI and rectal EUS indicated that the tumor only invaded muscular layer (T2).
  5. No suspicious lymphatic metastasis or distant metastasis was found on preoperative high-resolution CT and MRI.
  6. American Society of Anesthesiologists(ASA) grade I-III.
  7. Informed consent.
  8. No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

  1. Age<18, or>75.
  2. Have other cancer history.
  3. The pathology of rectal tumors is non-adenocarcinoma.
  4. Multiple primary colorectal tumors.
  5. Preoperative CT and MR showed that lymphatic metastasis and distant metastasis could be positive.
  6. Pregnant or lactating women.
  7. Patients with severe mental disorders.
  8. ASA score > 3.
  9. Receive other cancer treatments (radiotherapy, chemotherapy).
  10. Complication with other intestinal diseases (FAP, HNPCC, active ulcerative colitis or Crohn's disease).
  11. The general situation is poor and there are other uncontrollable diseases.
  12. Preoperative tumor stage was not T2N0M0.

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 identifier (NCT number): NCT04098471

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Contact: Yueming Sun, PhD 02568306026

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
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Study Director: Yueming Sun, PhD The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University Identifier: NCT04098471    
Other Study ID Numbers: CRSYM201909
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
transanal local excision
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases