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NCT Number: NCT06012214

RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy

This is a prospectively randomized controlled trial to compare RAMIE and MIE in the treatment for locally advanced ESCC after neoadjuvant therapy. According to previous studies, long-term survival after RAMIE seemed to be at least comparable to MIE or open esophagectomy. Therefore, the RAMIE-2 study was designed as a non-inferiority trial, which was based on the hypothesis that the 5-year overall survival of patients who received RAMIE is uncompromised to MIE. To achieve the primary endpoint, 260 cases will be recruited in our hospital. Based on the volume of esophagectomy (1000 cases/year) and the proportion of patients with neoadjuvant therapy (50%) in our institution, approximately 10 patients will be enrolled for each group per month for this trial. The study will be performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Written informed consent will be obtained from each participant. The flow chart of this trial is also presented.

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Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, SH 21, China

About this study

Neoadjuvant therapy followed by radical resection is the recommended treatment for locally advanced esophageal cancer, which could achieve a better R0 resection and overall survival. With the development of multidisciplinary treatment of esophageal cancer, especially the emerging concept of "watch and wait", surgery may only be a new era of salvage treatment for patients with poor response to neoadjuvant or recurrence after definitive treatment in the future. At that time, the technical advantage of RAMIE should be even more valuable. Early results of the RAMIE trial (conducted by our group)15, has demonstrated that RAMIE can achieve shorter operative time as well as better lymph node dissection in patients who received neoadjuvant therapy, compared to conventional MIE. In addition, this benefit was more obviously observed in lymph nodes along the bilateral recurrent laryngeal nerves, which were considered as the most challenging steps.

Therefore, we put forward a hypothesis: whether the robot's superior human-surgical interface is beneficial to achieve better surgical and oncological results in patients with locally advanced ESCC after neoadjuvant therapy. Based on the results of RAMIE trial, the present RAMIE-2 study is trying to answer such a question.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ranges from 18 to 75 years;
  • European Clinical Oncology Group Performance Status (ECOG PS) 0-2;
  • Histological subtype of esophageal squamous cell carcinoma;
  • Primary tumors are located at the intrathoracic esophagus;
  • Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition);
  • With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy;
  • Without any anticancer therapy for other malignant diseases;
  • Written informed consent.

Exclusion criteria

  • Cervical esophageal cancer and carcinoma of gastro-esophageal junction;
  • Patients with unresectable or metastatic esophageal cancer;
  • Histological subtype of esophageal non-squamous cell carcinoma;
  • History of previous thoracic surgery;
  • Patients with other malignant tumor (previous or current);
  • Participation in another clinical trial during this study.

Treatment and study plan

ROBOTIC-ASSISTED ESOPHAGECTOMY

Procedure

Comparison between robotic and conventional minimally invasive esophagectomy

Primary outcomes

  1. overall survival

    Time frame: up to 5 years

    defined as the time from the date of surgery to the day of death or to the last follow-up.

Secondary outcomes

  1. disease-free survival

    Time frame: up to 5 year

    defined as the time from the date of surgery to the day of tumor recurrence, tumor progression or death assessed up to 5 years

  2. oncologic results

    Time frame: 4 weeks

    number of lymph nodes dissection, R0 resection rate

Study contacts

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

Yang Yang, Dr.

CONTACT

[email protected]

86 21-22200000*2116

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

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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