Biomarkers and Functional Imaging in Predicting Response of Esophageal Cancer

NCT03029793 | Unknown

• 1 other identifier: XJFL-2016-ESO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether combination of molecular and biomarkers with functional imaging can predict pathologic response and clinical outcomes in squamous esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant chemoradiotherapy and surgery

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Prediction; Biomarker; MRI-DWI; PET-CT

Outcome Measures

Primary Outcomes (1)

• Pathologic Response

  Mandard tumor regression grade (TRG) was used for pathology analysis. Primary tumor and positive lymph node regression were classified into five histologic tumor regression grades. Grade 1 (complete regression) showed absence of histologically identifiable residual cancer and fibrosis extending through the different layers of the esophageal wall, with or without granuloma. Grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis. Grade 3 involved an increase in the number of residual cancer cells, but fibrosis still predominated. Grade 4 showed residual cancer outgrowing fibrosis. Grade 5 was characterized by the absence of regressive changes.

  Approximately 12 months

Secondary Outcomes (1)

• Overall Survival

  Approximately 4 years

Study Arms (1)

Biomarkers and Imaging analysis

This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, perform CRT resistance biomarkers testing and functional imaging analysis including SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI before treatment, 2-3 weeks after the initiation of CRT, and 4 weeks post-nCRT. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients. The investigators will also establish a model for survival prediction.

Other: Biomarkers Testing; Other: Functional Imaging analysis

Interventions

Biomarkers Testing OTHER

CRT resistance biomarkers will be detected before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.

Biomarkers and Imaging analysis

Functional Imaging analysis OTHER

The SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI will be measures before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.

Biomarkers and Imaging analysis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with localized carcinoma of the esophagus

You may qualify if:

• Patient must have histologic documentation of squamous carcinoma of the esophagus at Xijing Hospital.
• Newly diagnosed Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at Xijing Hospital and are considered appropriate candidates for and are willing to undergo chemoradiotherapy followed by surgery at Xijing Hospital.
• Patient must have undergone a baseline esophageal-gastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at Xijing, with tissue available for biomarker analysis.
• Patient must be willing to undergo this research and must provide written informed consent.

You may not qualify if:

• Patient is unable or unwilling to comply with the requirements of the protocol.
• History of prior malignancy within the past 3 years.
• Patients with second primary tumors.
• Patients who received endoscopical therapy or induction chemotherapy prior to chemoradiation therapy are excluded.
• Patient is not a candidate for chemoradiation followed by surgery.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Mei Shi, MD

  Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

  STUDY CHAIR

Central Study Contacts

Li-Na Zhao, MD, Ph.D

CONTACT

+86-29-84775425; zhaolinazln@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 24, 2017
• Study Start: May 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)