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Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

Completed
Conditions
Locally Advanced Rectal Cancer
Interventions
Diagnostic Test: pelvic MR examination
Registration Number
NCT03238885
Lead Sponsor
Sun Ying-Shi
Brief Summary

This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

Detailed Description

We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
538
Inclusion Criteria
  • pathologically proved rectal cancer
  • locally advanced rectal cancer (≥T3 or N+)
  • a distance less than 12cm between the lower edge of tumor and the anal margin
  • no evidence of distant metastases
  • no prior anti-cancer therapy before treatment
  • scheduled to receive preoperative CRT
Exclusion Criteria
  • history or concurrent of other malignancy
  • incomplete preoperative CRT
  • failed to receive surgery or unavailable pCR assessment
  • poor quality of MR images for measurement
  • patient quit

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
LARC-CRTpelvic MR examinationLARC patients who will receive neoadjuvant CRT before surgical resection.
Primary Outcome Measures
NameTimeMethod
Pathological complete response(pCR)within one week after surgery

Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Beijing Cancer Hospital

🇨🇳

Beijing, Beijing, China

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