NCT06012214Not yet recruiting
RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy
Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 15 Jun 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06012214
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Jan 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous thoracic surgery;
- Patients with other malignant tumor (previous or current);
Other illness
- Cervical esophageal cancer and carcinoma of gastro-esophageal junction;
- Patients with unresectable or metastatic esophageal cancer;
Other
- Histological subtype of esophageal non-squamous cell carcinoma;
- Participation in another clinical trial during this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital, Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.