Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI

NCT04392609 | Unknown

• 1 other identifier: MR-NT-2020
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.

Conditions

Rectal Cancer; MRI

Outcome Measures

Primary Outcomes (1)

• pTRG

  pathological tumour regression grading

  within 2 week after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019.

You may qualify if:

• pathological diagnosis of rectal cancer;
• received neoadjuvant chemoradiotherapy before surgery;
• before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum.
• before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or MRI showed that the lower margin of the tumor was within 12cm from the anal margin;
• pre-neoadjuvant clinical stage II/III (AJCC 7th edition);

You may not qualify if:

• simultaneous distant metastatic tumor should be considered at the first diagnosis;
• patients with distant metastasis were not considered at the initial diagnosis;
• with other malignant tumors;
• before neoadjuvant therapy, patients had received other relevant treatments;
• to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;

Sponsors & Collaborators

• Ziqiang Wang,MD: lead

Study Sites (1)

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

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

Central Study Contacts

Ziqiang Wang, MD

CONTACT

18980602028; wangtrial@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: January 15, 2020
• Primary Completion: June 15, 2020
• Study Completion: July 15, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

CN (1)