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NCT Number: NCT06644352

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

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

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Yin Li, MD

CONTACT

[email protected]

861087788052

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

different thoracic surgical approaches

Procedure

Right Versus Left Thoracic Surgical Approaches

Primary outcomes

  1. OS rate

    Time frame: 5 years

    OS is defined as the time from randomization to death due to any cause.

Secondary outcomes

  1. DFS rate

    Time frame: 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.

  2. pCR rate

    Time frame: 1 month after resection

    PCR is defined as pT0N0M0

  3. MPR rate

    Time frame: 1 month after resection

    MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.

  4. Operative Complications

    Time frame: perioperative period

    Operative Complications

Study contacts

Contact information is provided by the study sponsor or research team.

Yin Li, MD

CONTACT

[email protected]

+8601087788052

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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