Overview
In this study, investigators seek for a better way to identify the potential pathologic complete response (pCR) patients form non-pCR patients with locally advanced rectal cancer (LARC), based on their post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data.
Previously, a post neoadjuvant treatment MRI based radiomics AI model had been constructed and trained. The predictive power of this artificial intelligence system and expert radiologist to identify pCR patients from non-pCR LARC patients will be compared in this randomized controlled, prospective, multicenter, observational clinical study.
Description
This is a randomized controlled, multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post- neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical II-III staging without distant metastasis will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. All participants should follow a standard treatment protocol, including neoadjuvant treatment, total mesorectum excision (TME) surgery and adjuvant chemotherapy. Patients with LARC who received neoadjuvant treatment will be randomly assigned into two arms, and their post-neoadjuvant treatment MRI images will be used to predict their pathologic response (pCR vs. non-pCR). Patients in arm A assign to the artificial intelligence prediction system. While in group B, the patients assign to the expert radiologist prediction. The pathologist will provide the final pathology report of TME surgery specimen (pCR or non-pCR) as a standard. The predictive efficacy of these two arms will be compared in this randomized controlled, multicenter clinical study among patients with locally advanced rectal cancer.
Eligibility
Inclusion Criteria:
- pathologically diagnosed as rectal adenocarcinoma
- defined as clinical II-III staging (T3, and/or positive nodal status) without distant metastasis
- receive neoadjuvant chemoradiotherapy or chemotherapy
- pre- and post-neoadjuvant treatment MRI data obtained
- receive total mesorectum excision (TME) surgery after neoadjuvant therapy and get the pathologic assessment of tumor response
Exclusion Criteria:
- with history of other cancer
- insufficient imaging quality of MRI to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts)
- not completing neoadjuvant chemotherapy or chemoradiotherapy
- tumor recurrence or distant metastasis during neoadjuvant treatment
- not undergoing surgery resulting in lack of pathologic assessment of tumor response