Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

NCT02640586 | Unknown DMC

• 1 other identifier: PNTRRC-MRI
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery

  A scoring system for predicting pCR will be developed based on MRI parameters and their changes between baseline and early MRI. No viable cancer cells seen in the resection specimen is regarded as pCR

  2 years

• Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR

  A scoring system for predicting pCR will be developed based on MRI parameters

  2 years

Secondary Outcomes (4)

• Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)

  2 years

• Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy

  2 years

• MRI-predicted pCR and MRI-predicted response on long-term disease control and survival

  3 years

• Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)

  2 years

Study Arms (1)

Assessing response with MRI

EXPERIMENTAL

Preoperative chemo-radiotherapy as standard treatment. Neoadjuvant therapy (long course intensity modulated radio-chemotherapy, GTV 50.6Gy, totally 22 fractions; Capecitabine 825mg/m2 /bid by oral administration). Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy. All patients are scheduled to receive total mesorectal excision surgery 12-14 weeks after the completion of preoperative chemo-radiotherapy.

Device: three MR examination

Interventions

three MR examination DEVICE

Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.

Also known as: imaging

Assessing response with MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• T3/4 or node positive biopsy-proved primary rectal cancer
• Suitable for pre-operative chemoradiotherapy and surgical resection
• No contraindication to MRI
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• History or concurrent of other cancer
• Previous therapy to pelvis
• Unable/unwilling to have MRI
• Pacemaker or implanted defibrillator
• Pregnancy, lactation or inadequate contraception
• Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study
• Unwilling or unable to give informed consent

Sponsors & Collaborators

• Sun Ying-Shi: lead

Study Sites (11)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Location

Beijing Friendship Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Chinese Academy of Medical Sciences, Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Guangxi Cancer Hospital

Guilin, Guangxi, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ying-Shi Sun, MD

  No.52 Fu Cheng Road, Hai Dian District, Beijing, 10142

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Department of Radiology

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 29, 2015
• Study Start: January 10, 2016
• Primary Completion: July 17, 2020
• Study Completion: December 31, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)