NCT03238885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

5.8 years

First QC Date

August 1, 2017

Last Update Submit

January 31, 2019

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response(pCR)

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

    within one week after surgery

Study Arms (1)

LARC-CRT

LARC patients who will receive neoadjuvant CRT before surgical resection.

Diagnostic Test: pelvic MR examination

Interventions

pelvic MR examinationDIAGNOSTIC_TEST

All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.

LARC-CRT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

LARC patients who will undergo neoadiuvant CRT before surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Study Officials

  • Ying-Shi Sun

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

March 1, 2013

Primary Completion

December 18, 2018

Study Completion

January 21, 2019

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)