Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer

Diffusion-weighted Magnetic Resonance Imaging(DW-MRI) for Early Response Assessment of Neoadjuvant Chemoradiation Therapy(Neo-CRT) in Patients With Esophageal Squamous Cell Carcinoma(ESCC)

Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25% patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%. Concurrent chemoradiation followed by surgery results in better survival than single-modality treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent chemoradiation as preoperative or definitive treatment for patients with stage II or III esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup of these patients, and its toxicity can increase perioperative mortality and delay or preclude surgery. The ability to distinguish tumors that will respond or not respond to such therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is based on the extent of mobility of water protons, as quantified by the apparent diffusion coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules within tissues, which is mainly influenced by cell organization, size, and density. Cell death leads to a loss of cell membrane integrity and density and leads to increases in ADC values. The ADC has emerged as a potential biomarker of response to cancer therapy. However, no one has published findings regarding the potential correlation between changes in ADC and response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of DW-MRI for predicting response to such therapy is important for the delivery of appropriately tailored treatment.

Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high risk of treatment failure from such therapy. Investigators will test this hypothesis with two specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and (2) assess the ability of ADC to predict disease-free survival and overall survival.

Study Overview

• Status: Unknown
• Conditions: Esophageal Carcinoma
• Intervention / Treatment: Device: DW-MRI

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan province tumor pospital
      • Contact: shengqi wu, M.D.; Phone Number: 13807316075; Email: wushengqi@hnszlyy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible participants will have histologically confirmed esophageal squamous cell carcinoma with no contraindications for receiving neoadjvuant chemoradiation followed by surgery. All participants will be required to give informed consent to participate in the protocol, which has been approved by the review boards of the participating institutions.

Description

Inclusion Criteria:

• T1bN+ M0(T1b means that tumor invades submucosa) or T2-T4aN0/+ M0 (T4a means resectable tumor invading pleura, pericardium, or diaphragm) according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
• Pathological identified esophageal squamous cell cancer
• Karnofsky Performance Status（KPS）≥70
• Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
• Without severe other diseases
• Informed consent

Exclusion Criteria:

• Cervical esophagus cancer;
• Had received prior chemotherapy and thoracic radiotherapy
• Distant metastasis before treatment, including: pleural, pericardial or peritoneal cytology ,involvement of distant organs including the lungs, liver, bone, brain or non-regional lymph nodes
• Pregnant and lactating women
• Serious complications
• Other primary malignancies
• Cannot perform DW-MRI at specified time

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic response	Pathologic response will be assessed after surgery by two pathologists blinded to clinical and radiologic findings in the surgical specimen as follows : P0: no residual cancer cells P1: 1%-50% residual cancer cells; rare individual cancer cells or minute clusters of cancer cells P2: More than 50% residual cancer cells, often grossly identifiable at primary site	after surgury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is defined as the time (in months) from the date of admission to the date of death from any cause or last follow-up	up to 60 months
Progression free survival	Overall survival is defined as the time (in months) from the date of admission to the date of progression	up to 60 months

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital
• Collaborators: Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 16, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Response; Diffusion-weighted magnetic resonance imaging; Preoperative concurrent chemoradiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Body Weight; Esophageal Neoplasms
• Other Study ID Numbers: 89000--0000