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

Esophageal Carcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02527057
• Other study ID #: 89000--0000
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2015
• Last updated: August 15, 2016
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Device:
• DW-MRI
Participants will perform four DW-MRI scanning as follows,before chemoradiation , at 2 weeks , 4 weeks after the start of radiotherapy and before the surgery.If participants can not receive surgery,the last scanning time will replaced at the end of radiotherapy.

Locations

Country	Name	City	State
China	Hunan province tumor pospital	Changsha	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital	Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No