Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Esophageal cancer (EC) is the seventh most frequently diagnosed cancers and the sixth leading causes of cancer death worldwide . It is one of the most common malignancy in China, with the third highest morbidity and mortality rate. More than 90% of patients with EC in China have esophageal squamous cell carcinoma (ESCC). Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is currently widely used strategy for locally advanced surgical EC.
At present, conventional imaging methods have certain defects (focus only on the volume change) in the evaluation of the efficacy of nCRT. Whereas functional imaging can more comprehensively reflect the biological and microstructural characterization of tumors. The changes of these aspects of tumors can be observed earlier than volumetric changes of tumors.
The normal metabolism of the body is the basis for ensuring life activities. Due to the increased energy demand and proliferation of tumor tissue in patients with cancer, the metabolism of patients is different from that of normal person. Thus, the metabolic alterations seen in cancer cells have emerged as one of the hallmarks of cancer. Previous metabolomic studies have demonstrated various metabolic alterations in patients with ESCC. Many metabolites have been found to be promising diagnostic, staging or prognostic biomarkers for ESCC. However, there are few studies on metabolic markers on the chemoradiation sensitivity of esophageal cancer.
Therefore, the aim of the present study is to evaluate the value of functional imaging parameters and metabolic markers in assessing and predicting pathological response in patients who underwent nCRT for ESCC.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemoradiotherapy of local advanced ESCC | All the patients receive paclitaxel/cisplatin chemotherapy and concurrent radiotherapy. Each patient receives radiation of 41.4 Gy / 23 fractions complied by intensity modulated radiotherapy or volumetric modulated arc therapy. Patients without disease progression after nCRT will be scheduled for surgery and patients with disease progression (PD) will continue to receive chemoradiation or additional treatments. Surgery will be performed 6 to 8 weeks after completion of chemoradiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging (MRI) | Diagnostic Test | Anatomical (T2W) and functional MRI (DWI) at a 3.0T Siemens or Philips scanner Three MRI scan series (before, during, after nCRT) Measurements: change in apparent diffusion coefficient (ADC) |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathologic response | Histopathologic response of the primary tumor to nCRT according to the tumor regression grade (TRG) scale as determined by expert pathologist. TRG 1(pCR): no residual viable tumor cells, pathologic complete response TRG 2: rare residual cancer cells TRG 3: predominant fibrosis with increased number of residual cancer cells TRG 4: residual cancer outgrowing fibrosis or no regressive change | Based on resection specimen (surgery 6-8 weeks after finishing nCRT) |
| ∆ADC | change of apparent diffusion coefficient in DW-MRI and difference between pCR group and non-pCR group | within 2 weeks before the start of nCRT,2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT |
| ∆TLG | change of total lesion glycolysis in PET/CT and difference between pCR group and non-pCR group | within 2 weeks before the start of nCRT,2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT |
| change of metabolites | change of metabolites after chemoradiotherapy and differences between pCR group and non-pCR group | within 2 weeks before the start of nCRT and 4-6 weeks after the completion of nCRT |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | time to locoregional or distal recurrence | Up to 5-year follow-up |
| Overall survival | time to die or follow-up deadline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with resectable esophageal or gastroesophageal squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiumei Ma, Doctor | Contact | 13611983139 | sallyma@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
Not provided
Not provided
Not provided
Not provided
serum and urine
|
| 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) | Diagnostic Test | PET-CT scan at diagnosis and 4-6 weeks after nCRT before operation Measurements: change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value),MTV(Metabolic tumor volume) |
|
|
| Blood and urine metabolic biomarker | Diagnostic Test | Blood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy. |
|
| Up to 5-year follow-up |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D014057 | Tomography, X-Ray Computed |
| D000072078 | Positron Emission Tomography Computed Tomography |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D064847 | Multimodal Imaging |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided