MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer

NCT05609149 | Completed

• 1 other identifier: GIHSYSU-30
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Neoadjuvant treatment; Mesorectal fascia; Extramural vascular invasion

Outcome Measures

Primary Outcomes (1)

• 3-year event-free survival rate

  3 years after the surgery

Secondary Outcomes (2)

• 3-year overall survival rate

  3 years after the surgery

• Local recurrence

  3 years after the surgery

Study Arms (1)

T3 Rectal cancer

Patients with T3 rectal cancer who underwent curative surgery.

Procedure: total mesorectal excision

Interventions

total mesorectal excision PROCEDURE

patients must underwent total mesorectal excision

T3 Rectal cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer patients with T3Nx or T1-3N+ at initial diagnosis.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 8, 2022
• Study Start: October 30, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 2, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

CN (1)