Actively Recruiting
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
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-10-16
236
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the five-year overall survival of two different surgical approaches—the right versus left thoracic methods—for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma who have been treated with neoadjuvant chemotherapy. The study focuses on comparing these approaches in patients with specific tumor stages and operative conditions to understand which may offer better outcomes. Participants receive a combination of treatments starting with neoadjuvant chemotherapy consisting of 2 to 4 cycles, followed by surgery using either the right thoracic approach or the left thoracic approach, which involves different surgical incisions and lymph node removal. After surgery, patients continue with adjuvant chemotherapy to complete a total of 8 cycles including the initial neoadjuvant treatment. During the study, participants will be monitored for overall survival over five years, as well as disease-free survival over three years, pathological response rates shortly after surgery, and any operative complications during the perioperative period. The study involves multiple assessments to evaluate these outcomes, with careful follow-up to track the long-term effects and safety of the surgical approaches.
CONDITIONS
Brief Title
Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastroesophageal adenocarcinoma
- R0 resectable Siewert II, cT2-3N0-3M0 (AJCC V8 TNM classification)
- ECOG Performance Status of 0 or 1
- Age between 18 and 80 years, any gender
- Estimated survival of 6 months or more
- Able and willing to provide written informed consent
- Adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before enrollment
- No prior systemic or local treatment for esophageal cancer
You will not qualify if you...
- History of other malignant tumors
- Previous upper abdominal surgery except cholecystectomy
- Bleeding, perforation, or obstruction requiring emergency surgery
- Severe heart, lung, liver, or kidney dysfunction unsuitable for surgery
- Hydrothorax or ascites needing therapeutic puncture or drainage
- Participation in another clinical study within the past month
- History of psychoactive drug abuse, alcoholism, or drug abuse
- Unable or unwilling to cover inspection and treatment costs personally
- Investigator judgment that exclusion is necessary
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 2 to 4 chemotherapy cycles
Participants receive 2 to 4 cycles of chemotherapy before surgery to help shrink the tumor.
Multiple chemotherapy visits depending on cycle schedule
Duration - Surgical procedure and immediate recovery
Participants undergo surgery via either the right or left thoracic approach to remove the tumor and perform lymphadenectomy.
1 surgical hospitalization
Duration - Remaining chemotherapy cycles to complete total of 8 cycles
Participants receive additional chemotherapy cycles after surgery as part of perioperative treatment, completing a total of 8 chemotherapy cycles including neoadjuvant therapy.
Multiple chemotherapy visits depending on cycle schedule
Duration - Up to 5 years
Participants are monitored after completion of treatment for outcomes including survival and complications.
Periodic visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Y
Yin Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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