Esophageal CarcinomaNCT02527057
Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer
An observational study of Esophageal Carcinoma, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25% patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Carcinoma
- What is being tested?
- DW-MRI
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2019
- 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: Eligible participants will have histologically confirmed esophageal squamous cell carcinoma with no contraindications for receiving neoadjvuant chemoradiation followed by surgery. All participants will be required to give informed consent to participate in the protocol, which has been approved by the review boards of the participating institutions.
Who may be able to join
- T1bN+ M0(T1b means that tumor invades submucosa) or T2-T4aN0/+ M0 (T4a means resectable tumor invading pleura, pericardium, or diaphragm) according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
- Pathological identified esophageal squamous cell cancer
- Karnofsky Performance Status（KPS）≥70
- Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
- Without severe other diseases
- Informed consent
Who cannot join
- Cervical esophagus cancer;
- Had received prior chemotherapy and thoracic radiotherapy
- Distant metastasis before treatment, including: pleural, pericardial or peritoneal cytology ,involvement of distant organs including the lungs, liver, bone, brain or non-regional lymph nodes
- Pregnant and lactating women
- Serious complications
- Other primary malignancies
- Cannot perform DW-MRI at specified time
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan province tumor pospital
Changsha, Hunan
shengqi wu, M.D., 13807316075, wushengqi@hnszlyy.com
About this study
Official title: Diffusion-weighted Magnetic Resonance Imaging(DW-MRI) for Early Response Assessment of Neoadjuvant Chemoradiation Therapy(Neo-CRT) in Patients With Esophageal Squamous Cell Carcinoma(ESCC)
Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25% patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%. Concurrent chemoradiation followed by surgery results in better survival than single-modality treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent chemoradiation as preoperative or definitive treatment for patients with stage II or III esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup of these patients, and its toxicity can increase perioperative mortality and delay or preclude surgery. The ability to distinguish tumors that will respond or not respond to such therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is based on the extent of mobility of water protons, as quantified by the apparent diffusion coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules within tissues, which is mainly influenced by cell organization, size, and density. Cell death leads to a loss of cell membrane integrity and density and leads to increases in ADC values. The ADC has emerged as a potential biomarker of response to cancer therapy. However, no one has published findings regarding the potential correlation between changes in ADC and response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of DW-MRI for predicting response to such therapy is important for the delivery of appropriately tailored treatment.
Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high risk of treatment failure from such therapy. Investigators will test this hypothesis with two specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and (2) assess the ability of ADC to predict disease-free survival and overall survival.
- Conditions
- Esophageal Carcinoma
- Being tested
- DW-MRI
- Keywords
- Diffusion-weighted magnetic resonance imaging, Preoperative concurrent chemoradiation, Response
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-MRIDevice
Participants will perform four DW-MRI scanning as follows,before chemoradiation , at 2 weeks , 4 weeks after the start of radiotherapy and before the surgery.If participants can not receive surgery,the last scanning time will replaced at the end of radiotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response
Pathologic response will be assessed after surgery by two pathologists blinded to clinical and radiologic findings in the surgical specimen as follows : P0: no residual cancer cells P1: 1%-50% residual cancer cells; rare individual cancer cells or minute clusters of cancer cells P2: More than 50% residual cancer cells, often grossly identifiable at primary site
Measured: after surgury
Secondary outcomes (2)
Overall survival
Overall survival is defined as the time (in months) from the date of admission to the date of death from any cause or last follow-up
Measured: up to 60 months
Progression free survival
Overall survival is defined as the time (in months) from the date of admission to the date of progression
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University
- Responsible party
- Principal investigator, Hui Wang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527057
- Sponsor's protocol ID
- 89000--0000
- Status last verified
- Aug 2016
- First submitted
- 14 Aug 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-weighted Magnetic Resonance Imaging(DW-MRI) for Early Response Assessment of Neoadjuvant Chemoradiation Therapy(Neo-CRT) in Patients With Esophageal Squamous Cell Carcinoma(ESCC)
- ClinicalTrials.gov ID
- NCT02527057
- Acronym / sponsor ID
- 89000--0000
- Conditions
- Esophageal Carcinoma
- Keywords
- Diffusion-weighted magnetic resonance imaging, Preoperative concurrent chemoradiation, Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Aug 2015 (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.
Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25% patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%. Concurrent chemoradiation followed by surgery results in better survival than single-modality treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent chemoradiation as preoperative or definitive treatment for patients with stage II or III esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup of these patients, and its toxicity can increase perioperative mortality and delay or preclude surgery. The ability to distinguish tumors that will respond or not respond to such therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is based on the extent of mobility of water protons, as quantified by the apparent diffusion coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules within tissues, which is mainly influenced by cell organization, size, and density. Cell death leads to a loss of cell membrane integrity and density and leads to increases in ADC values. The ADC has emerged as a potential biomarker of response to cancer therapy. However, no one has published findings regarding the potential correlation between changes in ADC and response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of DW-MRI for predicting response to such therapy is important for the delivery of appropriately tailored treatment.
Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high risk of treatment failure from such therapy. Investigators will test this hypothesis with two specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and (2) assess the ability of ADC to predict disease-free survival and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will have histologically confirmed esophageal squamous cell carcinoma with no contraindications for receiving neoadjvuant chemoradiation followed by surgery. All participants will be required to give informed consent to participate in the protocol, which has been approved by the review boards of the participating institutions.
Key inclusion criteria (6 listed)
- T1bN+ M0(T1b means that tumor invades submucosa) or T2-T4aN0/+ M0 (T4a means resectable tumor invading pleura, pericardium, or diaphragm) according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
- Pathological identified esophageal squamous cell cancer
- Karnofsky Performance Status（KPS）≥70
- Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
- Without severe other diseases
Key exclusion criteria (7 listed)
- Cervical esophagus cancer;
- Had received prior chemotherapy and thoracic radiotherapy
- Distant metastasis before treatment, including: pleural, pericardial or peritoneal cytology ,involvement of distant organs including the lungs, liver, bone, brain or non-regional lymph nodes
- Pregnant and lactating women
- Serious complications
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 |
|---|---|---|
| DW-MRIParticipants will perform four DW-MRI scanning as follows,before chemoradiation , at 2 weeks , 4 weeks after the start of radiotherapy and before the surgery.If participants can not receive surgery,the last scanning time will replaced at the end of radiotherapy. | Device | – |
Primary outcome
Pathologic response
Time frame: after surgury
Pathologic response will be assessed after surgery by two pathologists blinded to clinical and radiologic findings in the surgical specimen as follows : P0: no residual cancer cells P1: 1%-50% residual cancer cells; rare individual cancer cells or minute clusters of cancer cells P2: More than 50% residual cancer cells, often grossly identifiable at primary site
2 secondary outcomes
Overall survival
Time frame: up to 60 months
Progression free survival
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
Related trials for Esophageal Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Active, not recruitingPhase 2
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers
Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer
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 Carcinoma, run by Hunan Province Tumor 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 6 inclusion and 7 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 17 Aug 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response (time frame: after surgury). 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 17 Aug 2016.