Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

Sun Ying-Shi

Status: Active, not recruiting

Conditions: Rectal Neoplasms

Treatments: Device: three MR examination

Study type: Interventional

Funder types: Other

Identifiers

NCT02640586

PNTRRC-MRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,614 participants in 1 patient group

Assessing response with MRI

Experimental group

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.

Treatment:

Device: three MR examination