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

NCT ID: NCT04392609

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2020-07-15

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.

Detailed Description

This study was designed as a retrospective case-control study. All 116 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. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times.

Conditions

Rectal Cancer; MRI

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. pathological diagnosis of rectal cancer;

2. received neoadjuvant chemoradiotherapy before surgery;

3. before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum.

4. 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;

5. pre-neoadjuvant clinical stage II/III (AJCC 7th edition);

Exclusion Criteria

1. simultaneous distant metastatic tumor should be considered at the first diagnosis;

2. patients with distant metastasis were not considered at the initial diagnosis;

3. with other malignant tumors;

4. before neoadjuvant therapy, patients had received other relevant treatments;

5. to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziqiang Wang,MD

OTHER

Sponsor Role: lead

Responsible Party

Ziqiang Wang,MD

physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ziqiang Wang, MD

Role: CONTACT

wangtrial@163.com

18980602028

Facility Contacts

Ziqiang Wang, MD

Role: primary

wangtrial@163.com

18980602028

Other Identifiers

MR-NT-2020

Identifier Type: -

Identifier Source: org_study_id