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

NCT03431428 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2018-02-13

No results posted yet for this study

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

Interventions

PROCEDURE

transanal surgery

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

PROCEDURE

Miles surgery

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

DRUG

Preoperative chemoradiotherapy

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

Sponsors & Collaborators

  • Zhang Rui

    lead OTHER

Principal Investigators

  • peirong ding, doctor · Sun Yat-sen University

  • ji zhu, doctor · Fudan University

  • zhenning wang, doctor · First Hospital of China Medical University

  • hong zhang, doctor · Shengjing Hospital

  • yu han, doctor · The Second Affiliated Hospital of Harbin Medical University

  • zhaocheng chi, doctor · Jilin Provincial Tumor Hospital

  • quan wang, doctor · The First Hospital of Jilin University

  • ge liu, doctor · The First Affiliated Hospital of Dalian Medical University

  • hang lu, doctor · Jinzhou Medical University

  • zheng liu, doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • rui Zhang, doctor · Liaoning Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-01-01
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431428 on ClinicalTrials.gov