Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

Rectal Neoplasms Clinical Trial

Official title:

Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02640586
• Other study ID #: PNTRRC-MRI
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1614
• Est. completion date: December 31, 2023
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Ying-Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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