Status:
UNKNOWN
Post-Neoadjuvant Treatment MRI Based AI System to Predict pCR for Rectal Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborating Sponsors:
Sir Run Run Shaw Hospital
The Third Affiliated Hospital of Kunming Medical College.
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
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 thei...
Detailed Description
This is a 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) b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04278274
Start Date
February 8 2020
End Date
March 31 2023
Last Update
October 26 2022
Active Locations (3)
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1
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
2
The Third Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China, 650000
3
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000