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Clinical Trials/NCT03238885
NCT03238885
Completed
Not Applicable

Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method

Sun Ying-Shi1 site in 1 country538 target enrollmentMarch 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Locally Advanced Rectal Cancer
Sponsor
Sun Ying-Shi
Enrollment
538
Locations
1
Primary Endpoint
Pathological complete response(pCR)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2013
End Date
January 21, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Ying-Shi
Responsible Party
Sponsor Investigator
Principal Investigator

Sun Ying-Shi

Director

Peking University Cancer Hospital & Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pathological complete response(pCR)

Time Frame: within one week after surgery

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

Study Sites (1)

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