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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction

Treatments: Procedure: different thoracic surgical approaches

Study type: Interventional

Funder types: Other

Identifiers

NCT06644352

YLI

Details and patient eligibility

About

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

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Right thoracic approach

Experimental group

Description:

Neoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the right thoracic approach (right thoracic incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy).

Treatment:

Procedure: different thoracic surgical approaches

Left thoracic approach

Active Comparator group

Description:

Neoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the left thoracic approach (including right thoracic and abdominal incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy).

Treatment:

Procedure: different thoracic surgical approaches