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Trial record 18 of 386 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Neoplasms"

Biomarkers and Functional Imaging in Predicting Response of Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03029793
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Mei Shi, Fourth Military Medical University

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

Condition or disease Intervention/treatment
Esophageal Cancer Other: Biomarkers Testing Other: Functional Imaging analysis

Detailed Description:
The recommended care for the management of locally advanced esophageal cancers is neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy based on the NCCN guideline. The rate of pathologic complete response (pCR) after nCRT was around 25-30%, reflecting potential cure of unresectable esophageal cancer receiving CRT. Since esophagectomy might have substantial morbidity and mortality rate, establishing the model for predicting nCRT response and survival will guide neoadjuvant treatment decisions and personalized treatment. Thus surgery might be spared in some patients with complete responses after nCRT, and surgery could be selectively reserved for those with only partial or no response to CRT. However, reported models yield unsatisfactory results due to small sample size and low accuracy, and most cases were adenocarcinoma and few models were used to predict survival. This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, detect CRT resistance biomarkers, assess the SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI. 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. This model might possibly guide the personalized treatment for esophageal squamous cell carcinoma patients in China.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combination of Molecular Biomarkers and Functional Imaging in Predicting Pathologic Response and Clinical Outcomes in Squamous Esophageal Cancer Patients Who Undergo Trimodality Therapy
Study Start Date : May 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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

Other: Functional Imaging analysis
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.




Primary Outcome Measures :
  1. Pathologic Response [ Time Frame: Approximately 12 months ]
    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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Approximately 4 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with localized carcinoma of the esophagus
Criteria

Inclusion Criteria:

  1. Patient must have histologic documentation of squamous carcinoma of the esophagus at Xijing Hospital.
  2. 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.
  3. Patient must have undergone a baseline esophageal-gastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at Xijing, with tissue available for biomarker analysis.
  4. Patient must be willing to undergo this research and must provide written informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029793


Contacts
Contact: Li-Na Zhao, MD, Ph.D +86-29-84775425 zhaolinazln@outlook.com

Locations
China, Shaanxi
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Lina Zhao, MD, Ph.D    +86-029-84775425    zhaolinazln@outlook.com   
Principal Investigator: Lina Zhao, Ph.D         
Principal Investigator: Mei Shi, MD         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Study Chair: Mei Shi, MD Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Responsible Party: Mei Shi, Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03029793     History of Changes
Other Study ID Numbers: XJFL-2016-ESO
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mei Shi, Fourth Military Medical University:
Esophageal Cancer
Prediction
Biomarker
MRI-DWI
PET-CT

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases