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Recruiting NCT06644352

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

No phase Interventional Siewert Type II Adenocarcinoma of Esophagogastric Junction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: different thoracic surgical approaches.
Who it may be relevant to
Registry conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure different thoracic surgical approaches
    Right Versus Left Thoracic Surgical Approaches

Primary outcome measures

  • OS rate [Time frame: 5 years]
Secondary outcome measures (4)
  • DFS rate [Time frame: 3 years]
  • pCR rate [Time frame: 1 month after resection]
  • MPR rate [Time frame: 1 month after resection]
  • Operative Complications [Time frame: perioperative period]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed gastroesophageal adenocarcinoma;
  • R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
  • Have a performance status of 0 or 1 on the ECOG Performance Scale;
  • Age 18-80 years old, both men and women;
  • Estimated survival ≥6 months;
  • Be willing and able to provide written informed consent/assent for the trial;
  • Demonstrate adequate organ function ;
  • 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;
  • Have not received systemic or local treatment for esophageal cancer in the past.

Exclusion criteria

  • Have a history of other malignant tumors in the past or at the same time;
  • Previous upper abdominal surgery (excluding cholecystectomy);
  • Bleeding, perforation and obstruction requiring emergency surgical treatment;
  • Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;
  • Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;
  • Participate in other clinical studies or less than 1 month from the end of the previous clinical study;
  • Have a history of psychoactive drug abuse, alcoholism or drug abuse;
  • Be unable or do not agree to bear the inspection and treatment expenses at their own expense;
  • The researcher thinks that it should be excluded from this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06644352 · YLI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗