NCT02953418: REACH

RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia

Terminated NA Results posted Last updated 12 August 2020

What this trial tests

NA trial testing Radiofrequency ablation in Esophageal Squamous Cell Neoplasia (ESCN) in 34 participants. Terminated before completion.

Timeline

20 April 2017

Primary endpoint
20 July 2019

20 July 2019

Quick facts

Lead sponsor	Medtronic - MITG
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	20 April 2017
Primary completion	20 July 2019
Estimated completion	20 July 2019
Sites	1 location across China

Drugs / interventions tested

• Radiofrequency ablation

Conditions studied

• Esophageal Squamous Cell Neoplasia (ESCN) — all drugs for Esophageal Squamous Cell Neoplasia (ESCN) →

Sponsor

Medtronic - MITG — full company profile →

Who can join

Adults 18 to 85, any sex, with Esophageal Squamous Cell Neoplasia (ESCN). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects With Complete Response (CR) Primary · 12 month

The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session

Group	Value	95% CI
Radiofrequency Ablation	8

Complete Response at Three Months Secondary · 3 Months

Number of patients with a CR after primary RFA, defined as absence of MGIN or worse in any of the biopsies from the treatment area at the three months visit

Group	Value	95% CI
Radiofrequency Ablation	5

Complete Response Within the Treatment Area Secondary · 3, 6 and 12 Month

Number of patients demonstrating complete response within the treatment area (TA), defined as detection of ESCC in biopsy or resection specimen at any time within the first 12 months.

3 Month Complete Response

Group	Value	95% CI
Radiofrequency Ablation	5

6 Month Complete Response

Group	Value	95% CI
Radiofrequency Ablation	22

12 Month Complete Response

Group	Value	95% CI
Radiofrequency Ablation	14

Disease Progression Outside the Treatment Area Secondary · Initial, 3, 6, 9 and 12 month

Proportion of patients demonstrating MGIN or worse outside the TA during treatment phase or follow-up

Primary RFA

Group	Value	95% CI
Radiofrequency Ablation	1

3-Month

Group	Value	95% CI
Radiofrequency Ablation	9

6-Month

Group	Value	95% CI
Radiofrequency Ablation	6

9-Month

Group	Value	95% CI
Radiofrequency Ablation	4

12-Month

Group	Value	95% CI
Radiofrequency Ablation	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Radiofrequency Ablation

Serious: 3/34 (9%)

Deaths: 0/34

Serious adverse events (3 terms)

Reaction	System	Radiofrequency Ablation
Oesophageal stenosis	Gastrointestinal disorders	—
H1N1Influenza	Infections and infestations	—
Squamous cell carcinoma of the hypopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (1 terms — click to expand)

Reaction	System	Radiofrequency Ablation
Oesophageal stenosis	Gastrointestinal disorders	—

Most-reported serious reactions: Oesophageal stenosis, H1N1Influenza, Squamous cell carcinoma of the hypopharynx.

Data from ClinicalTrials.gov NCT02953418 adverse events section.

Sponsor's own description

Multicenter, prospective cohort clinical trial in greater China

Publications & conference data

No peer-reviewed publications indexed yet for this trial.