Back to resultsMRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy
Primary Purpose
Esophagus Cancer, Esophagogastric Junction Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MRI and CT
Ratiotherapy
Paclitaxel, platinum-based drug
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophagus Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction
- Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1a, according to AJCC 6th) based on standard primary staging by EUS and CT
- Age>18 years
- No distant metastasis other than supraclavicular lymph nodes
- No prior history of thoracic radiation or chemotherapy
- Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
- Informed consent
Exclusion Criteria:
- Contraindication for MRI scanning
- Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Pregnant or lactating females
- Contraindication for radiotherapy or chemotherapy
Sites / Locations
- Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esophageal or esophagogastric cancer
Arm Description
Outcomes
Primary Outcome Measures
Tumor response based on MRI and CT simulation
Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation
Evaluation of tumor heterogeneity with IBEX software
Using the average CT images for texture extraction. Histogram, gradient, cooccurrence, gray-tone difference, and filtration-based techniques are used for texture feature extraction. Models incorporating texture features are established to compare to models incorporating clinical prognostic factors alone.
Secondary Outcome Measures
Overall survival
Progress free survival
Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation
Full Information
NCT ID
NCT02988921
First Posted
December 5, 2016
Last Updated
December 29, 2018
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02988921
Brief Title
MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI) are advancing imaging technologies that have potential to overcome limitations of conventional staging methods, radiation treatment planning and the assessment of tumor response in esophageal or esophagogastric cancer. This study aimed to explore the value of MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume delineation as compared to CT simulation for patients with unresectable or potentially resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT texture features are also extracted before and during treatment to establish a model to predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of patients.
Detailed Description
Both DW-MRI and CT simulation will be performed before chemoradiotherapy and after 18-22 fractions. Also MRI will be performed after treatment. The investigators will contour based on the MRI image and compare this with the standard CT plan before and during treatment.
The predictive potential of initial tumor ADC, and change in ADC during and after treatment for tumor response will be assessed.
The average CT texture features not only in the present study but also of those who treated previously in our department (since 2014) will be extracted before and during chemoradiotherapy to establish a model to predict the prognosis of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Esophagogastric Junction Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Esophageal or esophagogastric cancer
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI and CT
Intervention Type
Radiation
Intervention Name(s)
Ratiotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, platinum-based drug
Primary Outcome Measure Information:
Title
Tumor response based on MRI and CT simulation
Time Frame
up to 8 weeks
Title
Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation
Time Frame
up to 8 weeks
Title
Evaluation of tumor heterogeneity with IBEX software
Description
Using the average CT images for texture extraction. Histogram, gradient, cooccurrence, gray-tone difference, and filtration-based techniques are used for texture feature extraction. Models incorporating texture features are established to compare to models incorporating clinical prognostic factors alone.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Title
Progress free survival
Time Frame
1 year
Title
Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction
Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1a, according to AJCC 6th) based on standard primary staging by EUS and CT
Age>18 years
No distant metastasis other than supraclavicular lymph nodes
No prior history of thoracic radiation or chemotherapy
Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
Informed consent
Exclusion Criteria:
Contraindication for MRI scanning
Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
Pregnant or lactating females
Contraindication for radiotherapy or chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com
12. IPD Sharing Statement
Learn more about this trial
MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy
We'll reach out to this number within 24 hrs