Comparing right and left thoracic surgical methods for treating a specific type of esophageal cancer

A Prospective, Randomized, Controlled, Multicenter Study Comparing the Right Versus Left Thoracic Surgical Approaches for Locally Advanced Siewert II Gastroesophageal Junction Adenocarcinoma After Neoadjuvant Chemotherapy

This study is testing whether surgery on the right or left side of the chest works better for people with a specific type of esophageal cancer after they've had chemotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06644352 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of right versus left thoracic surgical approaches in patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma who have undergone neoadjuvant chemotherapy. The primary focus is on evaluating the 5-year overall survival rates associated with each surgical method. Eligible participants will be those with histologically confirmed adenocarcinoma who meet specific inclusion criteria, including performance status and organ function. The study will involve different surgical interventions to determine which approach yields better outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with resectable Siewert II gastroesophageal adenocarcinoma and a performance status of 0 or 1.

Not a fit: Patients with a history of other malignancies, previous upper abdominal surgeries, or those requiring emergency surgical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients undergoing surgery for gastroesophageal junction adenocarcinoma.

How similar studies have performed: While there have been studies on surgical approaches for gastroesophageal cancer, this specific comparison of right versus left thoracic methods is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed gastroesophageal adenocarcinoma;
2. R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
4. Age 18-80 years old, both men and women;
5. Estimated survival ≥6 months;
6. Be willing and able to provide written informed consent/assent for the trial;
7. Demonstrate adequate organ function ;
8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days before enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
9. Have not received systemic or local treatment for esophageal cancer in the past.

Exclusion Criteria:

1. Have a history of other malignant tumors in the past or at the same time;
2. Previous upper abdominal surgery (excluding cholecystectomy);
3. Bleeding, perforation and obstruction requiring emergency surgical treatment;
4. Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;
5. Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;
6. Participate in other clinical studies or less than 1 month from the end of the previous clinical study;
7. Have a history of psychoactive drug abuse, alcoholism or drug abuse;
8. Be unable or do not agree to bear the inspection and treatment expenses at their own expense;
9. The researcher thinks that it should be excluded from this study.

Where this trial is running

Beijing

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yin Li, MD

Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction, GastroEsophageal Cancer, Surgical Incision, Left thoracic incision, Right thoracic incision, Neoadjuvant chemotherapy