Esophagectomy for Esophageal Cancer

Overseen By James Isbell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastatic disease, Positive margins, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the importance of the surgical edge, known as the circumferential resection margin (CRM), in individuals with esophageal cancer who have undergone an esophagectomy (surgery to remove the esophagus). Researchers aim to determine if the distance between leftover cancer cells and the surgical edge affects survival rates. Participants will be divided into three groups based on the proximity of remaining cancer cells to the surgical edge after surgery. This trial targets individuals diagnosed with specific types of esophageal cancer (adenocarcinoma or squamous cell carcinoma) and a certain tumor stage (T3).

As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that esophagectomy is safe for patients with esophageal cancer?

Research has shown that esophagectomy, a surgery to remove part or all of the esophagus, is a common treatment for esophageal cancer. Studies indicate that this surgery can lead to serious side effects. For instance, up to 20% of patients experience severe complications, such as breathing problems or long hospital stays. Additionally, about 5% of patients do not survive the surgery. Despite these risks, esophagectomy remains widely used because it can effectively treat the cancer. However, considering both the potential benefits and risks is important when evaluating this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to refine our understanding of esophagectomy, a surgical procedure used to treat esophageal cancer. Specifically, the trial looks at the circumferential resection margin (CRM), which is the edge of the tissue removed during surgery. By examining different CRM scenarios—where the tumor is more than 1 mm away, between 0-1 mm away, or right at the margin—scientists hope to gain insights into how these margins impact patient outcomes. This knowledge could lead to more precise surgical techniques, potentially improving survival rates and reducing the likelihood of cancer recurrence.

What evidence suggests that esophagectomy is effective for esophageal cancer?

Research has shown that esophagectomy, a surgery to remove part of the esophagus, is a common treatment for esophageal cancer. One study found that 52% of patients who underwent a hybrid minimally invasive esophagectomy (HMIE) were disease-free after five years, compared to 44% of those who had traditional open surgery. However, the overall five-year survival rate for esophageal cancer remains low, around 20%. Despite these challenges, esophagectomy remains an important treatment option, especially for more advanced cases. Results can vary based on tumor size and other personal factors. Participants in this trial will be grouped based on the circumferential resection margin (CRM) status, which may influence outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniela Molena, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy

Pathologic staged T3 tumors (pT3)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Review

Evaluation of the prognostic significance of the circumferential resection margin (CRM) in patients with esophageal cancer undergoing resection

Retrospective analysis

Follow-up

Participants are monitored for overall survival and progression-free survival after surgery

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Esophagectomy

How Is the Trial Designed?

Group I: Circumferential resection margin (CRM)-close Experimental Treatment 1 Intervention

Participants will have a diagnosis of esophageal carcinoma and residual tumor \>0-1 mm from the CRM

Group II: Circumferential resection margin (CRM)+ Experimental Treatment 1 Intervention

Participants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM

Group III: Circumferential resection margin (CRM) Experimental Treatment 1 Intervention

Participants will have a diagnosis of esophageal carcinoma and residual tumor \>1 mm from the CRM

Esophagectomy is already approved in European Union, United States, Japan, China for the following indications:

Approved in European Union as Esophagectomy for:

• Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus

Approved in United States as Esophagectomy for:

• Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
• Other esophageal cancers

Approved in Japan as Esophagectomy for:

• Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus

Approved in China as Esophagectomy for:

• Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2632530/

Outcomes After Surgery for Esophageal Cancer - PMC

A meta-analysis of published results of 119 patients undergoing resection demonstrated an incidence of invasive cancer rate of 47%, an operative mortality of ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0748798325001647

What are the outcomes for long-term survivors after ...

Twenty patients died after the 5-year time point, 9 of these due to progression of their esophageal cancer. Nineteen patients developed a second primary ...

3.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2776431

Five-Year Survival Outcomes of Hybrid Minimally Invasive ...

The 5-year DFS was 52% (95% CI, 42%-61%) in the HMIE group vs 44% (95% CI, 34%-53%) in the open esophagectomy group (HR, 0.81; 95% CI, 0.55-1.17) ...

4.

aoe.amegroups.org

aoe.amegroups.org/article/view/8274/html

An update on developments in curative treatment for locally ...

The overall 5-year survival of esophageal cancer remains poor at approximately 20%. However, in patients with locally advanced esophageal ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2912110/

Esophagectomy for T1 esophageal cancer

The outcome for patients with esophageal carcinoma continues to be poor with a 5-year survival rate of 14% (1). With increasing use of endoscopic surveillance ...

6.

vats.amegroups.org

vats.amegroups.org/article/view/6039/html

Oncologic outcomes in minimally invasive esophagectomy for ...

Mortality rate for oesophageal resection in the modern era is close to 5% (5). Pulmonary complications and prolonged hospital stay due to complications are ...

7.

mdpi.com

mdpi.com/2072-6694/16/8/1468

Long-Term Impact of Severe Postoperative Complications ...

After esophageal resection for cancer, severe postoperative complications (SPCs) have been reported in up to 20% of patients. These are associated with ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0748798325004299

Surveillance frequency in resected esophageal cancer

In spite of advances in curative management of esophageal cancer, a significant proportion of patients have early recurrence following resection.