ESOPHAGEAL SQUAMOUS CELL CARCINOMANCT02047305
Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia
A study testing Radiofrequency Ablation in people with ESOPHAGEAL SQUAMOUS CELL CARCINOMA, run by Covidien, GI Solutions at 1 site in China.
Trial summary
Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ESOPHAGEAL SQUAMOUS CELL CARCINOMA
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18-80 years of age, inclusive
- Subject meets at least one of the following inclusion criteria:
- Within the last 3 months, subject demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus, or...
- within the last 3 months, subject demonstrated a new diagnosis of a flat-type (type 0-IIb) SCCA (G1/G2 only)
- On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
- The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
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- Baseline EUS (all patients) shows no exclusionary findings for the trial
- CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial
- Subject is not pregnant nor has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test)
- Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
- The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
Who cannot join
- the Eligibility CRF.
- Esophageal stricture preventing passage of a therapeutic endoscope
- Any prior endoscopic resection
- Any esophageal dilation in the past 12 months
- Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage) prior to 3 months before screening for this trial
- Any N or M positive status, if patient has a present diagnosis of esophageal SCCA
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- Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus.
- Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc)
- Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
- Evidence of eosinophilic esophagitis on endoscopy and/or histology
- Report of uncontrolled coagulopathy with international normalized ratio (INR) > 2 or platelet count <75,000 platelets per µL (note: a complete blood count is not required for all subjects in this study)
- Subject is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that can not be discontinued 7 days before and after therapeutic sessions
- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
- Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
- Subject has life expectancy less than 2 years
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: A Single-center Trial of Endoscopic Radiofrequency Ablation of Moderate and High-grade Intra-epithelial Squamous Neoplasia and Early Flat-type Squamous Cell Carcinoma Using the HALO Ablation System
Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.
Read the detailed description
A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.
- Conditions
- ESOPHAGEAL SQUAMOUS CELL CARCINOMA
- Being tested
- Radiofrequency Ablation
- Keywords
- ESCN, RFA
- 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.
Radiofrequency AblationDevice
Also called RFA, Barrx ablation system, HALO ablation system
Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Experimental | To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
The percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2009
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ESOPHAGEAL SQUAMOUS CELL 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covidien, GI Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guiqi Wang, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047305
- Sponsor's protocol ID
- B300
- Status last verified
- Mar 2020
- First submitted
- 24 Jan 2014
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
He S, Bergman J, Zhang Y, Weusten B, Xue L, Qin X, Dou L, Liu Y, Fleischer D, Lu N, Dawsey SM, Wang GQ. Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial. Endoscopy. 2015 May;47(5):398-408. doi: 10.1055/s-0034-1391285. Epub 2015 Feb 10.
PubMed 25668428Bergman JJ, Zhang YM, He S, Weusten B, Xue L, Fleischer DE, Lu N, Dawsey SM, Wang GQ. Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus. Gastrointest Endosc. 2011 Dec;74(6):1181-90. doi: 10.1016/j.gie.2011.05.024. Epub 2011 Aug 15.
PubMed 21839994Yu X, van Munster SN, Zhang Y, Xue L, Fleischer DE, Weusten BLAM, Lu N, Dawsey SSM, Bergman JJGHM, Wang G. Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China. Gastrointest Endosc. 2019 Apr;89(4):736-748.e2. doi: 10.1016/j.gie.2018.10.030. Epub 2018 Oct 26.
PubMed 30905354
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Trial of Endoscopic Radiofrequency Ablation of Moderate and High-grade Intra-epithelial Squamous Neoplasia and Early Flat-type Squamous Cell Carcinoma Using the HALO Ablation System
- ClinicalTrials.gov ID
- NCT02047305
- Acronym / sponsor ID
- B300
- Conditions
- ESOPHAGEAL SQUAMOUS CELL CARCINOMA
- Keywords
- ESCN, RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Covidien, GI SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.
Detailed description
A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Experimental | Device: Radiofrequency AblationTo study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is 18-80 years of age, inclusive
- Subject meets at least one of the following inclusion criteria:
- On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
- The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
- Baseline EUS (all patients) shows no exclusionary findings for the trial
Key exclusion criteria (16 listed)
- the Eligibility CRF.
- Esophageal stricture preventing passage of a therapeutic endoscope
- Any prior endoscopic resection
- Any esophageal dilation in the past 12 months
- Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage) prior to 3 months before screening for this trial
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 |
|---|---|---|
| Radiofrequency AblationAlso: RFA, Barrx ablation system, HALO ablation systemPatients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals. | Device | Radiofrequency ablation |
Primary outcome
Complete Response
Time frame: 12 Month
The percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25668428He S, Bergman J, Zhang Y, Weusten B, Xue L, Qin X, Dou L, Liu Y, Fleischer D, Lu N, Dawsey SM, Wang GQ. Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial. Endoscopy. 2015 May;47(5):398-408. doi: 10.1055/s-0034-1391285. Epub 2015 Feb 10.
- Results publication: PubMed 21839994Bergman JJ, Zhang YM, He S, Weusten B, Xue L, Fleischer DE, Lu N, Dawsey SM, Wang GQ. Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus. Gastrointest Endosc. 2011 Dec;74(6):1181-90. doi: 10.1016/j.gie.2011.05.024. Epub 2011 Aug 15.
- Derived from this study: PubMed 30905354Yu X, van Munster SN, Zhang Y, Xue L, Fleischer DE, Weusten BLAM, Lu N, Dawsey SSM, Bergman JJGHM, Wang G. Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China. Gastrointest Endosc. 2019 Apr;89(4):736-748.e2. doi: 10.1016/j.gie.2018.10.030. Epub 2018 Oct 26.
- 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.
Guiqi Wang, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with ESOPHAGEAL SQUAMOUS CELL CARCINOMA, run by Covidien, GI Solutions 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 11 inclusion and 16 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: finished, as of the sponsor's last update on 21 May 2020. 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?
Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: 12 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02047305, which also lists 3 linked publications.
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 21 May 2020.