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Trial Title:
Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT06644352
Condition:
Siewert Type II Adenocarcinoma of Esophagogastric Junction
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
GastroEsophageal Cancer
Surgical Incision
Left thoracic incision
Right thoracic incision
Neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
different thoracic surgical approaches
Description:
Right Versus Left Thoracic Surgical Approaches
Arm group label:
Left thoracic approach
Arm group label:
Right thoracic approach
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yin Li, MD
Phone:
861087788052
Email:
liyin@cicams.ac.cn
Start date:
July 1, 2022
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644352
