Esophageal CancerNCT02448953
Two-field Versus Three-field Lymphadenectomy in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement
A study testing Two-field lymphadenectomy and Three-field lymphadenectomy in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Two-field lymphadenectomy and Three-field lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy;
- Preoperative clinical TNM stage：cT1b-3N0-1M0;
- Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS;
- No evidence of suspicious neck lymph node metastasis (LN short diameter < 0.8cm or LN short/long diameter <0.65 by cervical CT and/or ultrasound);
- Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail
Who cannot join
- Previous use of anti-cancer therapy;
- Preoperative clinical TNM stage: N2-3 or M1;
- Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
- Previous malignancy history.
- Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound);
- Unwilling to participate the clinical trial and refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yousheng Mao, MD, 8610-87787138, maoysherx@126.com
Zhirong Zhang, MD, 8610-87788798, zhangzr@cicams.ac.cn
About this study
Official title: Comparison of Lymph Node Dissection Results and Prognosis in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement: Two-field Versus Three-field Lymph Node Dissection
The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.
Read the detailed description
Esophageal carcinoma is a prevalent and aggressive malignant disease with poor prognosis in China. Complete surgical resection with systemic lymph node dissection remains the most effective treatment method for this malignancy. Although tree-field lymph node dissection was reported to be effective in improving long-term survival in Japan,there is no enough evidences yet to demonstrate that three field lymph node dissection is superior to two field lymph node dissection in reducing postoperative recurrence and improving long-term survival. In this study, the dissection of lymph node adjacent to the right recurrent laryngeal nerve would be performed and examined routinely by intraoperative frozen-section. If the lymph node is positive, three field lymph node dissection(Cervical-thoracic-upper abdominal lymphadenectomy) will be performed, if negative, the patients will be randomly assigned either to three-field lymphadenectomy group or two-field lymphadenectomy group. The purpose of this large scale multi-center trial is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma without cervical lymph node involvement treated by three-field lymphadenectomy or two-field lymphadenectomy and clarify whether the lymph node along the right recurrent laryngeal nerve could be taken as sentinel lymph node indicating neck lymph node metastasis and necessity of three-field lymphadenectomy.
- Conditions
- Esophageal Cancer
- Being tested
- Two-field lymphadenectomy, Three-field lymphadenectomy
- Keywords
- Without cervical lymph node involvement
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-field lymphadenectomyProcedure or surgery
Thoracic-upper abdominal two-field lymphadenectomy
Three-field lymphadenectomyProcedure or surgery
Cervical-thoracic-upper abdominal three-field completely lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| negative lymph node | Active comparator | lymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination Receives: Procedure: Two-field lymphadenectomy; Procedure: Three-field lymphadenectomy |
| positive lymph node | Active comparator | lymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination Receives: Procedure: Three-field lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term survival
Measured: 5 years
Secondary outcomes (3)
Disease free survival
Measured: 5 years
Locoregional recurrence
Measured: 5 years
Postoperative complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- 786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Henan Cancer Hospital, Hebei Medical University Fourth Hospital, Sichuan Cancer Hospital and Research Institute, Fujian Cancer Hospital, Liaoning Cancer Hospital & Institute, Zhejiang Cancer Hospital, Tongji Hospital, Tang-Du Hospital, Shanghai Chest Hospital
- Responsible party
- Principal investigator, Jie He, Chinese Academy of Medical Sciences
- Investigators
- Jie He, MD,PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448953
- Sponsor's protocol ID
- NKTRDP-2015BAI12B08-03
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mao Y, Liu S, Han Y, Guo S, Chen C, Gao S, Hao A, Duan H, Fang W, Zhang R, Yu Z, Fu X, Li X, Wang Q, Tan L, Li Z, Li Y, Zhang Z, Wei W, Fang Y, Fu D, Wei X, Yuan L, Muhammad S, He J. Three-field vs two-field lymphadenectomy in thoracic ESCC patients: a multicenter randomized study (NST 1503). J Natl Cancer Cent. 2025 Jan 14;5(2):203-211. doi: 10.1016/j.jncc.2025.01.002. eCollection 2025 Apr.
PubMed 40265094
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lymph Node Dissection Results and Prognosis in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement: Two-field Versus Three-field Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT02448953
- Acronym / sponsor ID
- NKTRDP-2015BAI12B08-03
- Conditions
- Esophageal Cancer
- Keywords
- Without cervical lymph node involvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Henan Cancer Hospital, Hebei Medical University Fourth Hospital, Sichuan Cancer Hospital and Research Institute, Fujian Cancer Hospital, Liaoning Cancer Hospital & Institute, Zhejiang Cancer Hospital, Tongji Hospital, Tang-Du Hospital, Shanghai Chest Hospital
- Study start
- Jan 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 May 2015 (estimated)
- 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.
The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.
Detailed description
Esophageal carcinoma is a prevalent and aggressive malignant disease with poor prognosis in China. Complete surgical resection with systemic lymph node dissection remains the most effective treatment method for this malignancy. Although tree-field lymph node dissection was reported to be effective in improving long-term survival in Japan,there is no enough evidences yet to demonstrate that three field lymph node dissection is superior to two field lymph node dissection in reducing postoperative recurrence and improving long-term survival. In this study, the dissection of lymph node adjacent to the right recurrent laryngeal nerve would be performed and examined routinely by intraoperative frozen-section. If the lymph node is positive, three field lymph node dissection(Cervical-thoracic-upper abdominal lymphadenectomy) will be performed, if negative, the patients will be randomly assigned either to three-field lymphadenectomy group or two-field lymphadenectomy group. The purpose of this large scale multi-center trial is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma without cervical lymph node involvement treated by three-field lymphadenectomy or two-field lymphadenectomy and clarify whether the lymph node along the right recurrent laryngeal nerve could be taken as sentinel lymph node indicating neck lymph node metastasis and necessity of three-field lymphadenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| negative lymph node | Active comparator | Procedure: Two-field lymphadenectomy, Procedure: Three-field lymphadenectomylymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination |
| positive lymph node | Active comparator | Procedure: Three-field lymphadenectomylymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy;
- Preoperative clinical TNM stage：cT1b-3N0-1M0;
- Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS;
- No evidence of suspicious neck lymph node metastasis (LN short diameter < 0.8cm or LN short/long diameter <0.65 by cervical CT and/or ultrasound);
- Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail
Key exclusion criteria (6 listed)
- Previous use of anti-cancer therapy;
- Preoperative clinical TNM stage: N2-3 or M1;
- Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
- Previous malignancy history.
- Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound);
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 |
|---|---|---|
| Two-field lymphadenectomyThoracic-upper abdominal two-field lymphadenectomy | Procedure or surgery | negative lymph node |
| Three-field lymphadenectomyCervical-thoracic-upper abdominal three-field completely lymphadenectomy | Procedure or surgery | negative lymph node, positive lymph node |
Primary outcome
Long term survival
Time frame: 5 years
3 secondary outcomes
Disease free survival
Time frame: 5 years
Locoregional recurrence
Time frame: 5 years
Postoperative complications
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Derived from this study: PubMed 40265094Mao Y, Liu S, Han Y, Guo S, Chen C, Gao S, Hao A, Duan H, Fang W, Zhang R, Yu Z, Fu X, Li X, Wang Q, Tan L, Li Z, Li Y, Zhang Z, Wei W, Fang Y, Fu D, Wei X, Yuan L, Muhammad S, He J. Three-field vs two-field lymphadenectomy in thoracic ESCC patients: a multicenter randomized study (NST 1503). J Natl Cancer Cent. 2025 Jan 14;5(2):203-211. doi: 10.1016/j.jncc.2025.01.002. eCollection 2025 Apr.
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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. This study is not recruiting at the moment.
Jie He, MD,PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-field lymphadenectomy and Three-field lymphadenectomy in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences 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 5 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: status not confirmed, as of the sponsor's last update on 20 May 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousheng Mao, MD (8610-87787138, maoysherx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448953, which also lists 1 linked publication.
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 20 May 2015.