Endoscopic Ablation Techniques for Barrett's Esophagus

Recruiting at 5 trial locations

Overseen By Sachin Wani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Squamous cell carcinoma

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Variable, based on treatment modality

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals with Barrett's esophagus (a condition where the esophagus lining changes) and esophageal cancer. It evaluates the effectiveness of endoscopic eradication therapies (EET) for Barrett's esophagus and examines how surgery and other treatments can aid those with invasive esophageal cancer. Individuals with Barrett's esophagus or esophageal cancer, excluding those with squamous cell carcinoma, might be suitable candidates. Those dealing with Barrett's-related issues and seeking advanced treatment options may find this trial of interest. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from promising new therapies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that endoscopic eradication therapies (EET) are generally safe and well-tolerated for treating Barrett's esophagus with abnormal cells. Studies have found that these treatments can effectively remove these cells, and most patients recover well. Some might experience minor issues like discomfort or bleeding, but serious problems are rare.

For those with invasive esophageal cancer, esophagectomy is another option. This surgery, which removes the esophagus, can be more intense and may involve risks like lung issues or longer hospital stays. However, survival rates are encouraging, and improvements in surgical methods have led to better outcomes.

In summary, both treatments are considered safe for most patients, though they have different risks. Discussing these options with a healthcare provider is important when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the TREAT-BE approach for Barrett's Esophagus because it combines endoscopic eradication therapies (EET) with esophagectomy in a novel way. Traditional treatments often rely on surgery or ablation separately, but this trial is exploring a combination strategy that could potentially improve outcomes by removing diseased tissue and then targeting remaining abnormal cells. For patients with early-stage Barrett's Esophagus, this method might offer a less invasive and more comprehensive treatment compared to surgery alone. Additionally, for those with invasive esophageal cancer, integrating multiple treatment modalities could enhance effectiveness and provide a more personalized approach.

What evidence suggests that this trial's treatments could be effective for esophageal cancer and Barrett's esophagus?

Research has shown that treatments using endoscopes, called endoscopic eradication therapies (EET), have greatly improved the management of Barrett's esophagus. These treatments can reduce the risk of developing serious cancer in individuals with this condition. For example, one type of EET, radiofrequency ablation (RFA), has been highly successful in treating dysplasia, a precancerous condition. Participants in this trial with Barrett's esophagus will undergo evaluation and treatment with EET.

In contrast, esophagectomy, the surgical removal of the esophagus, is a common treatment for serious esophageal cancer. Studies indicate that patients undergoing this surgery, particularly the less invasive version, have a survival rate of up to 50.5% over three years. Participants in this trial with invasive esophageal cancer will receive treatment through surgery, chemotherapy, radiation, and palliative care. Although these survival rates are encouraging, esophagectomy remains a major surgery requiring a long recovery period. ^{1 2 4 5 6}

Who Is on the Research Team?

Sachin Wani, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Evaluation

Initial evaluation includes collection of data on demographics, risk factors, and detailed medical history. Patients complete questionnaires regarding GERD symptoms and quality of life.

1-2 weeks

1 visit (in-person)

Treatment

Patients undergo endoscopic eradication therapy (EET) or esophagectomy, with documentation of endoscopic and histopathology results, and details of chemoradiation treatments.

Variable, based on treatment modality

Multiple visits (in-person)

Follow-up

Participants are monitored for long-term effectiveness or durability of EET, recurrence of neoplasia, and quality of life over a 5-year period.

5 years

Regular surveillance visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Endoscopic eradication therapies (EET)
• Esophagectomy
• Radiation

How Is the Trial Designed?

Group I: Patients with invasive esophageal cancer Experimental Treatment 3 Interventions

Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities.

Group II: Patients with Barrett's Esophagus Experimental Treatment 1 Intervention

Patients with non-dysplastic Barrett's esophagus, patients with Barrett's related dysplasia which includes low-grade dysplasia, high-grade dysplasia and intramucosal cancer who will be evaluated and treated with endoscopic eradication therapies (EET).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Feinberg School of Medicine, Northwestern University

Collaborator

Trials

34

Recruited

12,300+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+

California Pacific Medical Center

Collaborator

Trials

13

Recruited

8,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9275014/

Endoscopic eradication therapy for Barrett's oesophagus Unfortunately, EAC miss rates in Barrett's oesophagus are reported as high as 25% and we still have not impacted EAC outcomes at a population level [4,5].

2. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00302-0/fulltext

AGA Clinical Practice Guideline on Endoscopic Eradication ... The advent of endoscopic eradication therapy (EET) for treatment of dysplasia and early-stage cancer has revolutionized the management of Barrett's esophagus ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725000501?via%3Dihub

Long-term outcomes after endoscopic eradication therapy ... A total of 216 patients achieved CRIM and were then followed up for a median (IQR) 5.8 years (2.9-7.2 years). Intestinal metaplasia (IM) recurred in 57 patients ...

4. giejournal.org giejournal.org/article/S0016-5107(22)00121-3/fulltext

Endoscopic eradication therapy for Barrett's esophagus– ... We have shown long-term benefit of EET in reducing rates of invasive cancer in a large cohort of patients, with RFA alone achieving excellent ...

5. shc.amegroups.org shc.amegroups.org/article/view/5892/html

Endoscopic eradication therapies for Barrett's esophagus EMR using multiple techniques has been shown to be a safe method of endoscopic eradication therapy for BE with dysplasia (20-23). Complete eradication of ...

6. giejournal.org giejournal.org/article/S0016-5107(17)32408-2/fulltext

Endoscopic eradication therapy for patients with Barrett's ... Endoscopic eradication therapy (EET) has significantly changed the management of patients with BE-related neoplasia and allows a minimally ...