Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of nCRT for Locally Advanced ESCC
1 other identifier
observational
118
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 24, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 18, 2021
January 1, 2021
3 years
January 24, 2021
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (2)
Disease-free survival
Up to 5-year follow-up
Overall survival
Up to 5-year follow-up
Study Arms (1)
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.
Interventions
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)
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 specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy.
Eligibility Criteria
Patients with resectable esophageal or gastroesophageal squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy
You may qualify if:
- Pathologically confirmed esophageal squamous cell carcinoma；
- AJCC 7th edition staging T3-T4a or N+；
- No radiotherapy or chemotherapy in the past；
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
Biospecimen
serum and urine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2021
First Posted
February 18, 2021
Study Start
January 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 18, 2021
Record last verified: 2021-01