Back to resultsPredicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
Primary Purpose
Rectal Neoplasms
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
three MR examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Neoplasms
Eligibility Criteria
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
Sites / Locations
- Peking University Cancer Hospital
- Beijing Chao Yang Hospital
- Beijing Friendship Hospital Capital Medical University
- Chinese Academy of Medical Sciences, Cancer Hospital & Institute
- The First Affiliated Hospital of Chongqing Medical University
- Guangxi Cancer Hospital
- Hubei Cancer Hospital
- Hunan Cancer Hospital
- Jilin Cancer Hospital
- The First Affiliated Hospital of Jilin University
- Shanxi Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assessing response with MRI
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02640586
Brief Title
Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
Official Title
Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
July 17, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sun Ying-Shi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1614 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessing response with MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
three MR examination
Other Intervention Name(s)
imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery
Description
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
Time Frame
2 years
Title
Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR
Description
A scoring system for predicting pCR will be developed based on MRI parameters
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)
Description
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.
Time Frame
2 years
Title
Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy
Description
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.
Time Frame
2 years
Title
MRI-predicted pCR and MRI-predicted response on long-term disease control and survival
Description
3 years disease-free survival and overall survival will be assessed
Time Frame
3 years
Title
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)
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Shi Sun, MD
Organizational Affiliation
No.52 Fu Cheng Road, Hai Dian District, Beijing, 10142
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Chao Yang Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese Academy of Medical Sciences, Cancer Hospital & Institute
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Guangxi Cancer Hospital
City
Guilin
State/Province
Guangxi
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
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