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Completed

NCT Number: NCT05609149

MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer

This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

About this study

There is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. Existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC, however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant recurrence as well as poor overall survival. This retrospective study is designed to was to evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion (EMVI), or tumor deposits (TD) were defined as MRI high-risk.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Underwent primary rectal adenocarcinoma resection
  • Received MRI scan before surgery
  • Willing and able to provide written informed consent for participation in this study.
  • Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (<12 cm from the anal verge).
  • Clinical stage of T3Nx or T1-3N+ at initial diagnosis
  • Non-complicated primary tumor (complete obstruction, perforation, bleeding).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

  • Treated with transanal local excision
  • with distant metastases at the time of initial diagnosis
  • Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
  • Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).

Treatment and study plan

Total mesorectal excision

Procedure

patients must underwent total mesorectal excision

Primary outcomes

  1. 3-year event-free survival rate

    Time frame: 3 years after the surgery

Secondary outcomes

  1. 3-year overall survival rate

    Time frame: 3 years after the surgery

  2. Local recurrence

    Time frame: 3 years after the surgery

    Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Risk Criteria Based on MRI Features Outperform Radiographic TNM Staging in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer:A Single-Center, Open-Label, Retrospective, Observational Cohort Study

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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