ESOPHAGEAL SQUAMOUS CELL CARCINOMA
Conditions
Keywords
ESCN, RFA
Brief 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. 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.
Interventions
DEVICERadiofrequency Ablation
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.
Sponsors
Covidien, GI Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 18-80 years of age, inclusive 2. Subject meets at least one of the following inclusion criteria: 1. Within the last 3 months, subject demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus, or... 2. within the last 3 months, subject demonstrated a new diagnosis of a flat-type (type 0-IIb) SCCA (G1/G2 only) 3. 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 4. The maximum allowable linear length of USL-bearing esophagus is 12 cm 5. Baseline EUS (all patients) shows no exclusionary findings for the trial 6. CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial 7. 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) 8. Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol 9. The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
Exclusion criteria
the Eligibility CRF. 1. Esophageal stricture preventing passage of a therapeutic endoscope 2. Any prior endoscopic resection 3. Any esophageal dilation in the past 12 months 4. 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 5. Any N or M positive status, if patient has a present diagnosis of esophageal SCCA 6. 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. 7. Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc) 8. Evidence of esophageal varices detected within last 6 months or at initial RFA procedure 9. Evidence of eosinophilic esophagitis on endoscopy and/or histology 10. 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) 11. Subject is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that can not be discontinued 7 days before and after therapeutic sessions 12. 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 13. 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 14. Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol 15. Subject has life expectancy less than 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Ablation 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
Radiofrequency Ablation: 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. | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | Radiofrequency Ablation |
|---|---|
| Age, Customized Age | 59.9 years STANDARD_DEVIATION 6.6 |
| Body Mass Index | 23.4 (kg/m^2) STANDARD_DEVIATION 2.6 |
| Current Use of Alcohol | 32 Participants |
| Current Use of Tabacco | 29 Participants |
| Grade of esophageal neoplasia at study entry HGIN | 42 Participants |
| Grade of esophageal neoplasia at study entry MGIN | 45 Participants |
| Grade of esophageal neoplasia at study entry T1m2 ESCC | 9 Participants |
| History of Cancer Esophageal cancer | 15 Participants |
| History of Cancer History of any cancer in a first-degree relative | 29 Participants |
| Length of treatment area | 8.6 CM STANDARD_DEVIATION 2.9 |
| Length of unstained lesions | 6.5 CM STANDARD_DEVIATION 2.9 |
| Race/Ethnicity, Customized Chinese Ethnicity | 96 Participants |
| Region of Enrollment China | 96 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 96 |
| other Total, other adverse events | 25 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
Primary
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
Time frame: 12 Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiofrequency Ablation | Complete Response | 81 Participants |