Surgical Procedure, UnspecifiedNCT06012214
RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy
A study testing ROBOTIC-ASSISTED ESOPHAGECTOMY in people with Surgical Procedure, Unspecified, run by Shanghai Chest Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- ROBOTIC-ASSISTED ESOPHAGECTOMY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, SH 21
About this study
Official title: Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- ROBOTIC-ASSISTED ESOPHAGECTOMY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROBOTIC-ASSISTED ESOPHAGECTOMYProcedure or surgery
Comparison between robotic and conventional minimally invasive esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted minimally invasive esophagectomy | Experimental | Participants will received neoadjuvant therapy followed by robot-assisted minimally invasive esophagectomy within 8 weeks. Receives: Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY |
| Thoraco-laparoscopic minimally invasive esophagectomy | Placebo comparator | Participants will received neoadjuvant therapy followed by thoraco-laparoscopic minimally invasive esophagectomy within 8 weeks. Receives: Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
defined as the time from the date of surgery to the day of death or to the last follow-up.
Measured: up to 5 years
Secondary outcomes (2)
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
Measured: up to 5 year
oncologic results
number of lymph nodes dissection, R0 resection rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
- Investigators
- Zhigang Li, Dr., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012214
- Sponsor's protocol ID
- RAMIE-2
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06012214
- Acronym / sponsor ID
- RAMIE-2
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted minimally invasive esophagectomy | Experimental | Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMYParticipants will received neoadjuvant therapy followed by robot-assisted minimally invasive esophagectomy within 8 weeks. |
| Thoraco-laparoscopic minimally invasive esophagectomy | Placebo comparator | Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMYParticipants will received neoadjuvant therapy followed by thoraco-laparoscopic minimally invasive esophagectomy within 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROBOTIC-ASSISTED ESOPHAGECTOMYComparison between robotic and conventional minimally invasive esophagectomy | Procedure or surgery | Robot-assisted minimally invasive esophagectomy, Thoraco-laparoscopic minimally invasive esophagectomy |
Primary outcome
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.
2 secondary outcomes
disease-free survival
Time frame: up to 5 year
oncologic results
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhigang Li, Dr. principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROBOTIC-ASSISTED ESOPHAGECTOMY in people with Surgical Procedure, Unspecified, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Yang, Dr. (86 21-22200000*2116, yangyang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.