Siewert Type II Adenocarcinoma of Esophagogastric Junction
Conditions
Keywords
GastroEsophageal Cancer, Surgical Incision, Left thoracic incision, Right thoracic incision, Neoadjuvant chemotherapy
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
Interventions
PROCEDUREdifferent thoracic surgical approaches
Right Versus Left Thoracic Surgical Approaches
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS rate | 5 years | OS is defined as the time from randomization to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYin Li, MD
Outcome results
None listed