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

Not Applicable

Recruiting

• Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction

• Registration Number: NCT06644352
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2024-07-12
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
OS rate	5 years	OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
DFS rate	3 years	DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
pCR rate	1 month after resection	PCR is defined as pT0N0M0
MPR rate	1 month after resection	MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.
Operative Complications	perioperative period	Operative Complications

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China