RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012214
• Other study ID #: RAMIE-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: Shanghai Chest Hospital
• Contact: Yang Yang, Dr.
• Phone: 86 21-22200000*2116
• Email: yangyang[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age ranges from 18 to 75 years;

2. European Clinical Oncology Group Performance Status (ECOG PS) 0-2;

3. Histological subtype of esophageal squamous cell carcinoma;

4. Primary tumors are located at the intrathoracic esophagus;

5. Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition);

6. With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy;

7. Without any anticancer therapy for other malignant diseases;

8. Written informed consent.

Exclusion Criteria:

1. Cervical esophageal cancer and carcinoma of gastro-esophageal junction;

2. Patients with unresectable or metastatic esophageal cancer;

3. Histological subtype of esophageal non-squamous cell carcinoma;

4. History of previous thoracic surgery;

5. Patients with other malignant tumor (previous or current);

6. Participation in another clinical trial during this study.

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Procedure:
• ROBOTIC-ASSISTED ESOPHAGECTOMY
Comparison between robotic and conventional minimally invasive esophagectomy

Locations

Country	Name	City	State
China	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	defined as the time from the date of surgery to the day of death or to the last follow-up.	up to 5 years
Secondary	disease-free survival	defined as the time from the date of surgery to the day of tumor recurrence, tumor progression or death assessed up to 5 years	up to 5 year
Secondary	oncologic results	number of lymph nodes dissection, R0 resection rate	4 weeks