Esophageal CancerNCT03029793
Biomarkers and Functional Imaging in Predicting Response of Esophageal Cancer
An observational study of Esophageal Cancer, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to determine whether combination of molecular and biomarkers with functional imaging can predict pathologic response and clinical outcomes in squamous esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant chemoradiotherapy and surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Biomarkers Testing and Functional Imaging analysis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jan 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with localized carcinoma of the esophagus
Who may be able to join
- Patient must have histologic documentation of squamous carcinoma of the esophagus at Xijing Hospital.
- Newly diagnosed Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at Xijing Hospital and are considered appropriate candidates for and are willing to undergo chemoradiotherapy followed by surgery at Xijing Hospital.
- Patient must have undergone a baseline esophageal-gastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at Xijing, with tissue available for biomarker analysis.
- Patient must be willing to undergo this research and must provide written informed consent.
Who cannot join
- Patient is unable or unwilling to comply with the requirements of the protocol.
- History of prior malignancy within the past 3 years.
- Patients with second primary tumors.
- Patients who received endoscopical therapy or induction chemotherapy prior to chemoradiation therapy are excluded.
- Patient is not a candidate for chemoradiation followed by surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Lina Zhao, MD, Ph.D, +86-029-84775425, zhaolinazln@outlook.com
Lina Zhao, Ph.D
About this study
Official title: Combination of Molecular Biomarkers and Functional Imaging in Predicting Pathologic Response and Clinical Outcomes in Squamous Esophageal Cancer Patients Who Undergo Trimodality Therapy
The purpose of this study is to determine whether combination of molecular and biomarkers with functional imaging can predict pathologic response and clinical outcomes in squamous esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant chemoradiotherapy and surgery
Read the detailed description
The recommended care for the management of locally advanced esophageal cancers is neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy based on the NCCN guideline. The rate of pathologic complete response (pCR) after nCRT was around 25-30%, reflecting potential cure of unresectable esophageal cancer receiving CRT. Since esophagectomy might have substantial morbidity and mortality rate, establishing the model for predicting nCRT response and survival will guide neoadjuvant treatment decisions and personalized treatment. Thus surgery might be spared in some patients with complete responses after nCRT, and surgery could be selectively reserved for those with only partial or no response to CRT. However, reported models yield unsatisfactory results due to small sample size and low accuracy, and most cases were adenocarcinoma and few models were used to predict survival. This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, detect CRT resistance biomarkers, assess the SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients.The investigators will also establish a model for survival prediction. This model might possibly guide the personalized treatment for esophageal squamous cell carcinoma patients in China.
- Conditions
- Esophageal Cancer
- Being tested
- Biomarkers Testing, Functional Imaging analysis
- Keywords
- Esophageal Cancer, Prediction, Biomarker, MRI-DWI, PET-CT
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers TestingOther
CRT resistance biomarkers will be detected before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.
Functional Imaging analysisOther
The SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI will be measures before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.
| Study group | Role | What they receive |
|---|---|---|
| Biomarkers and Imaging analysis | This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, perform CRT resistance biomarkers testing and functional imaging analysis including SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI before treatment, 2-3 weeks after the initiation of CRT, and 4 weeks post-nCRT. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients. The investigators will also establish a model for survival prediction. Receives: Other: Biomarkers Testing; Other: Functional Imaging analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Response
Mandard tumor regression grade (TRG) was used for pathology analysis. Primary tumor and positive lymph node regression were classified into five histologic tumor regression grades. Grade 1 (complete regression) showed absence of histologically identifiable residual cancer and fibrosis extending through the different layers of the esophageal wall, with or without granuloma. Grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis. Grade 3 involved an increase in the number of residual cancer cells, but fibrosis still predominated. Grade 4 showed residual cancer outgrowing fibrosis. Grade 5 was characterized by the absence of regressive changes.
Measured: Approximately 12 months
Secondary outcomes (1)
Overall Survival
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Shi, Air Force Military Medical University, China
- Investigators
- Mei Shi, MD, Study chair, Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029793
- Sponsor's protocol ID
- XJFL-2016-ESO
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Molecular Biomarkers and Functional Imaging in Predicting Pathologic Response and Clinical Outcomes in Squamous Esophageal Cancer Patients Who Undergo Trimodality Therapy
- ClinicalTrials.gov ID
- NCT03029793
- Acronym / sponsor ID
- XJFL-2016-ESO
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Prediction, Biomarker, MRI-DWI, PET-CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
The purpose of this study is to determine whether combination of molecular and biomarkers with functional imaging can predict pathologic response and clinical outcomes in squamous esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant chemoradiotherapy and surgery
Detailed description
The recommended care for the management of locally advanced esophageal cancers is neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy based on the NCCN guideline. The rate of pathologic complete response (pCR) after nCRT was around 25-30%, reflecting potential cure of unresectable esophageal cancer receiving CRT. Since esophagectomy might have substantial morbidity and mortality rate, establishing the model for predicting nCRT response and survival will guide neoadjuvant treatment decisions and personalized treatment. Thus surgery might be spared in some patients with complete responses after nCRT, and surgery could be selectively reserved for those with only partial or no response to CRT. However, reported models yield unsatisfactory results due to small sample size and low accuracy, and most cases were adenocarcinoma and few models were used to predict survival. This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, detect CRT resistance biomarkers, assess the SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients.The investigators will also establish a model for survival prediction. This model might possibly guide the personalized treatment for esophageal squamous cell carcinoma patients in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarkers and Imaging analysis | – | Other: Biomarkers Testing, Other: Functional Imaging analysisThis study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, perform CRT resistance biomarkers testing and functional imaging analysis including SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI before treatment, 2-3 weeks after the initiation of CRT, and 4 weeks post-nCRT. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients. The investigators will also establish a model for survival prediction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized carcinoma of the esophagus
Key inclusion criteria (4 listed)
- Patient must have histologic documentation of squamous carcinoma of the esophagus at Xijing Hospital.
- Newly diagnosed Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at Xijing Hospital and are considered appropriate candidates for and are willing to undergo chemoradiotherapy followed by surgery at Xijing Hospital.
- Patient must have undergone a baseline esophageal-gastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at Xijing, with tissue available for biomarker analysis.
- Patient must be willing to undergo this research and must provide written informed consent.
Key exclusion criteria (5 listed)
- Patient is unable or unwilling to comply with the requirements of the protocol.
- History of prior malignancy within the past 3 years.
- Patients with second primary tumors.
- Patients who received endoscopical therapy or induction chemotherapy prior to chemoradiation therapy are excluded.
- Patient is not a candidate for chemoradiation followed by surgery.
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 |
|---|---|---|
| Biomarkers TestingCRT resistance biomarkers will be detected before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT. | Other | Biomarkers and Imaging analysis |
| Functional Imaging analysisThe SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI will be measures before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT. | Other | Biomarkers and Imaging analysis |
Primary outcome
Pathologic Response
Time frame: Approximately 12 months
Mandard tumor regression grade (TRG) was used for pathology analysis. Primary tumor and positive lymph node regression were classified into five histologic tumor regression grades. Grade 1 (complete regression) showed absence of histologically identifiable residual cancer and fibrosis extending through the different layers of the esophageal wall, with or without granuloma. Grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis. Grade 3 involved an increase in the number of residual cancer cells, but fibrosis still predominated. Grade 4 showed residual cancer outgrowing fibrosis. Grade 5 was characterized by the absence of regressive changes.
1 secondary outcome
Overall Survival
Time frame: Approximately 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Mei Shi, MD study chair
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
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 Cancer, run by Air Force Military Medical University, China 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 4 inclusion and 5 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 24 Jan 2017. 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 Li-Na Zhao, MD, Ph.D (+86-29-84775425, zhaolinazln@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Response (time frame: Approximately 12 months). 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 24 Jan 2017.