Esophageal Squamous Cell CarcinomaNCT04759235
Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of nCRT for Locally Advanced ESCC
An observational study of Esophageal Squamous Cell Carcinoma, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Magnetic resonance imaging (MRI), 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) and Blood and urine metabolic biomarker
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resectable esophageal or gastroesophageal squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Xiumei Ma, Doctor, 021-68383624, sallyma@hotmail.com
Xiumei Ma, Doctor
About this study
Official title: Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
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.
Read more
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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Magnetic resonance imaging (MRI), 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT), Blood and urine metabolic biomarker
- Keywords
- Neoadjuvant chemoradiotherapy, Esophageal Squamous Cell Carcinoma, Multimodal Functional Imaging, Metabolomics
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
Also called Diffusion-weighted magnetic resonance imaging (DW-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)
18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT)Diagnostic test
Also called PET, 18F-FDG-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）
Blood and urine metabolic biomarkerDiagnostic test
Blood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: within 2 weeks before the start of nCRT and 4-6 weeks after the completion of nCRT
Secondary outcomes (2)
Disease-free survival
time to locoregional or distal recurrence
Measured: Up to 5-year follow-up
Overall survival
time to die or follow-up deadline
Measured: Up to 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759235
- Sponsor's protocol ID
- KY2020-032
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04759235
- Acronym / sponsor ID
- KY2020-032
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Neoadjuvant chemoradiotherapy, Esophageal Squamous Cell Carcinoma, Multimodal Functional Imaging, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemoradiotherapy of local advanced ESCC | – | Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT), Diagnostic Test: Blood and urine metabolic biomarkerAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resectable esophageal or gastroesophageal squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (8 listed)
- Have received radiotherapy or systemic chemotherapy;
- During pregnancy or lactation;
- Uncontrollable serious medical diseases;
- Unable to sign informed consent;
- With distant metastasis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging (MRI)Also: Diffusion-weighted magnetic resonance imaging (DW-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) | Diagnostic test | neoadjuvant chemoradiotherapy of local advanced ESCC |
| 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT)Also: PET, 18F-FDG-PET/CTPET-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） | Diagnostic test | neoadjuvant chemoradiotherapy of local advanced ESCC |
| Blood and urine metabolic biomarkerBlood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy. | Diagnostic test | neoadjuvant chemoradiotherapy of local advanced ESCC |
Primary outcome
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
∆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
∆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
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
2 secondary outcomes
Disease-free survival
Time frame: Up to 5-year follow-up
Overall survival
Time frame: Up to 5-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiumei Ma, Doctor (13611983139, sallyma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathologic response (time frame: Based on resection specimen (surgery 6-8 weeks after finishing nCRT)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.