MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI and CT, Ratiotherapy, Paclitaxel, platinum-based drug.
- Who it may be relevant to
- Registry conditions: Esophagus Cancer, Esophagogastric Junction Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
1. 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. 2. The predictive potential of initial tumor ADC, and change in ADC during and after treatment for tumor response will be assessed. 3. 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.
Interventions
- Device MRI and CT
- Radiation Ratiotherapy
- Drug Paclitaxel, platinum-based drug
Primary outcome measures
- Tumor response based on MRI and CT simulation [Time frame: up to 8 weeks]
- Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation [Time frame: up to 8 weeks]
- Evaluation of tumor heterogeneity with IBEX software [Time frame: up to 8 weeks]
Secondary outcome measures (3)
- Overall survival [Time frame: 1 year]
- Progress free survival [Time frame: 1 year]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy — Beijing
Identifiers
NCT: NCT02988921 · 16-161/1240