RecruitingNot ApplicableNCT06644352

Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

236 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Summary

To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

Histologically confirmed gastroesophageal adenocarcinoma;
R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
Have a performance status of 0 or 1 on the ECOG Performance Scale;
Age 18-80 years old, both men and women;
Estimated survival ≥6 months;
Be willing and able to provide written informed consent/assent for the trial;
Demonstrate adequate organ function ;
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;
Have not received systemic or local treatment for esophageal cancer in the past.

Exclusion Criteria9

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