Clinical trial NCT02640586: Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
Official title: Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neoplasms
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 1614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery
timeFrame: 2 years
measure: Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR
timeFrame: 2 years
Secondary outcomes:
measure: Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)
timeFrame: 2 years
measure: Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy
timeFrame: 2 years
measure: MRI-predicted pCR and MRI-predicted response on long-term disease control and survival
timeFrame: 3 years
measure: 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)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Cancer Hospital & Institute
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guilin
country: China
facility: Guangxi Cancer Hospital
state: Guangxi
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
Study officials:
affiliation: No.52 Fu Cheng Road, Hai Dian District, Beijing, 10142
name: Ying-Shi Sun, MD
role: STUDY_CHAIR
References: