Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients

NCT03431428 | Unknown Phase 3

• 1 other identifier: 20171112
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.

Conditions

Almost-cCR; Surgery; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  The progression-free survival of 3 years

  three years

• OS

  3 years of overall survival time

  three years

Secondary Outcomes (7)

• carcinoembryonic antigen（CEA）

  every 3 months,for 2 years

• carbohydrate antigen 19-9（CA-199）

  every 3 months,for 2 years

• International Index of Erectile Function-15

  every 3 months ,for 2 years

• International prostate symptom score

  every 3 months ,for 2 years

• Female sexual function index

  every 3 months,for 2 years

Study Arms (2)

transanal surgery

EXPERIMENTAL

To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm. The intestinal wall was sutured to ensure the integrity of the bowel.

Procedure: transanal surgery; Drug: Preoperative chemoradiotherapy

Miles surgery

PLACEBO COMPARATOR

According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.

Procedure: Miles surgery; Drug: Preoperative chemoradiotherapy

Interventions

transanal surgery PROCEDURE

Transanal surgery could Preserve anus to reduce trauma and improve the quality of life

transanal surgery

Miles surgery PROCEDURE

Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.

Miles surgery

Preoperative chemoradiotherapy DRUG

After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.

Miles surgery; transanal surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histology is confirmed as rectal adenocarcinoma.
• to 75 years old.
• Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
• The anus couldn't be retained after TME.
• Almost-cCR or cCR recurrence during observation.

You may not qualify if:

• Patients were unable to tolerate the operation.
• Preoperative stage: T4b or progress during the treatment.
• HIV infection stage or chronic hepatitis B.
• Active clinical severe infections.
• Evil liquid state or decompensation of organ function.
• Other malignant tumor history in five years.
• Other primary carcinoma.
• Unstable condition and incompliance of the patient

Sponsors & Collaborators

• Zhang Rui: lead

Study Sites (1)

Liaoning cancer Hospital

Shenyang, Liaoning, China

RECRUITING

Related Publications (1)

• Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.

  PMID: 37310167 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transanal Endoscopic Surgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• peirong ding, doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• ji zhu, doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

• zhenning wang, doctor

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• hong zhang, doctor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• yu han, doctor

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• zhaocheng chi, doctor

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

• quan wang, doctor

  The First Bethune Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• ge liu, doctor

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• hang lu, doctor

  Jinzhou Medical University

  PRINCIPAL INVESTIGATOR

• zheng liu, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• rui Zhang, doctor

  Liaoning Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

rui zhang, doctor

CONTACT

8613898872185; zzzrrr1234@sina.com

xin liu, master

CONTACT

8618900918981; liuxin5626855@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of colorectal surgery,clinical professor

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: February 13, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2022
• Last Updated: February 13, 2018

Record last verified: 2017-12

Locations

CN (1)