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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessing response with MRI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| three MR examination | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying-Shi Sun, MD | No.52 Fu Cheng Road, Hai Dian District, Beijing, 10142 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Beijing Chao Yang Hospital |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Friendship Hospital Capital Medical University | Beijing | Beijing Municipality | China |
| Chinese Academy of Medical Sciences, Cancer Hospital & Institute | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Guangxi Cancer Hospital | Guilin | Guangxi | China |
| Hubei Cancer Hospital | Wuhan | Hubei | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| Jilin Cancer Hospital | Changchun | Jilin | China |
| The First Affiliated Hospital of Jilin University | Changchun | Jilin | China |
| Shanxi Cancer Hospital | Taiyuan | Shanxi | China |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |