Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Device: three MR examination

Detailed Description

We proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pCR) of patients with rectal cancer who received neoadjuvant chemoradiation. MR radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted MR images will be integrated for model construction.

• Study Type: Interventional
• Enrollment (Actual): 1614
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Peking University Cancer Hospital
    • Beijing, Beijing, China
      • Beijing Friendship Hospital Capital Medical University
    • Beijing, Beijing, China
      • Beijing Chao Yang Hospital
    • Beijing, Beijing, China
      • Chinese Academy of Medical Sciences, Cancer Hospital & Institute
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Guangxi
    • Guilin, Guangxi, China
      • Guangxi Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Jilin
    • Changchun, Jilin, China
      • Jilin Cancer Hospital
    • Changchun, Jilin, China
      • The First Affiliated Hospital of Jilin University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• T3/4 or node positive biopsy-proved primary rectal cancer
• Suitable for pre-operative chemoradiotherapy and surgical resection
• No contraindication to MRI
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• History or concurrent of other cancer
• Previous therapy to pelvis
• Unable/unwilling to have MRI
• Pacemaker or implanted defibrillator
• Pregnancy, lactation or inadequate contraception
• Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study
• Unwilling or unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Assessing response with MRI; Preoperative chemo-radiotherapy as standard treatment. Neoadjuvant therapy (long course intensity modulated radio-chemotherapy, GTV 50.6Gy, totally 22 fractions; Capecitabine 825mg/m2 /bid by oral administration). Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy. All patients are scheduled to receive total mesorectal excision surgery 12-14 weeks after the completion of preoperative chemo-radiotherapy.

Device: three MR examination; Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.; Other Names: imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery	A scoring system for predicting pCR will be developed based on MRI parameters and their changes between baseline and early MRI. No viable cancer cells seen in the resection specimen is regarded as pCR	2 years
Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR	A scoring system for predicting pCR will be developed based on MRI parameters	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)	A scoring system for predicting pathological response will be developed based on MRI parameters and their changes between baseline and early MRI.TRG1 is regarded as responder, and TRG2/3 is regarded as non-responder.	2 years
Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy	This will be assessed in terms of whether MR imaging at 7-9 weeks after preoperative radio-chemotherapy adds any additional predictive value to imaging performed 14-16 days after initiation of preoperative radio-chemotherapy.	2 years
MRI-predicted pCR and MRI-predicted response on long-term disease control and survival	3 years disease-free survival and overall survival will be assessed	3 years
Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)	A scoring system for predicting pathological response will be developed based on MRI parameters and their changes between baseline and early MRI.TRG1 is regarded as responder, and TRG2/3 is regarded as non-responder.	2 years

Collaborators and Investigators

• Sponsor: Sun Ying-Shi
• Investigators: Study Chair: Ying-Shi Sun, MD, No.52 Fu Cheng Road, Hai Dian District, Beijing, 10142

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2016
• Primary Completion (Actual): July 17, 2020
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimated): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PNTRRC-MRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No