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Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of nCRT for Locally Advanced ESCC

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ClinicalTrials.gov Identifier: NCT04759235
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Esophageal Squamous Cell Carcinoma Diagnostic Test: Magnetic resonance imaging (MRI) Diagnostic Test: 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) Diagnostic Test: Blood and urine metabolic biomarker

Study Design
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Study Type : Observational
Estimated Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Diagnostic Test: Magnetic resonance imaging (MRI)
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)
Other Name: Diffusion-weighted magnetic resonance imaging (DW-MRI)

Diagnostic Test: 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT)
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）
Other Names:
  • PET
  • 18F-FDG-PET/CT

Diagnostic Test: Blood and urine metabolic biomarker
Blood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Histopathologic response [ Time Frame: Based on resection specimen (surgery 6-8 weeks after finishing nCRT) ]
    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

  2. ∆ADC [ Time Frame: 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 apparent diffusion coefficient in DW-MRI and difference between pCR group and non-pCR group

  3. ∆TLG [ Time Frame: 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 total lesion glycolysis in PET/CT and difference between pCR group and non-pCR group

  4. change of metabolites [ Time Frame: within 2 weeks before the start of nCRT and 4-6 weeks after the completion of nCRT ]
    change of metabolites after chemoradiotherapy and differences between pCR group and non-pCR group


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: Up to 5-year follow-up ]
    time to locoregional or distal recurrence

  2. Overall survival [ Time Frame: Up to 5-year follow-up ]
    time to die or follow-up deadline


Biospecimen Retention:   Samples Without DNA
serum and urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with resectable esophageal or gastroesophageal squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy
Criteria

Inclusion Criteria:

  • Pathologically confirmed esophageal squamous cell carcinoma；
  • AJCC 7th edition staging T3-T4a or N+；
  • No radiotherapy or chemotherapy in the past；
  • 18-75 years old；
  • Hematology, biochemical and organ function indicators meet the following requirements: 1) White blood cells ≥ 3.0 x109/ L; 2)neutrophil cells ≥ 1.5 x109/ L; 3) Platelet count ≥85 x109/L; 4) Hemoglobin ≥90 g/L; 5) Total bilirubin ≤1.5 times normal value; 6) ALT≤ 1.5 x normal value; AST ≤1.5 times the normal value; 7) Serum creatinine ≤1.5 times the normal value, and creatinine clearance rate (Ccr) ≥60ml/min (Cockcroft-Gault);
  • ECOG score 0-1 points;
  • Able to eat a semi-liquid diet；
  • sign an informed consent.

Exclusion Criteria:

  • Have received radiotherapy or systemic chemotherapy;
  • During pregnancy or lactation;
  • Uncontrollable serious medical diseases;
  • Unable to sign informed consent;
  • With distant metastasis;
  • Suffering from the second type of malignant tumor (except skin squamous cell carcinoma and carcinoma in situ of other organs) within the past 5 years；
  • Those who cannot receive MRI examination;
  • Chemotherapy drugs or contrast agents Allergic.
Contacts and Locations
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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): NCT04759235


Contacts
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Contact: Xiumei Ma, Doctor 13611983139 sallyma@hotmail.com

Locations
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China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Xiumei Ma, Doctor    021-68383624    sallyma@hotmail.com   
Principal Investigator: Xiumei Ma, Doctor         
Sponsors and Collaborators
RenJi Hospital
More Information
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04759235    
Other Study ID Numbers: KY2020-032
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
Neoadjuvant chemoradiotherapy
Esophageal Squamous Cell Carcinoma
Multimodal Functional Imaging
Metabolomics
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action