Esophagus Cancer Clinical Trial
NCT number | NCT02988921 |
Other study ID # | 16-161/1240 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | December 2026 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response based on MRI and CT simulation | up to 8 weeks | ||
Primary | Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation | up to 8 weeks | ||
Primary | 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. | up to 8 weeks | |
Secondary | Overall survival | 1 year | ||
Secondary | Progress free survival | 1 year | ||
Secondary | Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation | 1 year |
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