Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

Study Overview
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Brief Summary
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There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. However, in Western countries patients with cervical lymph node metastases are generally precluded from curative treatment.

Detailed Description
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Objective: To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine the effect on survival and recurrence. Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level III and/ or IV. Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation. Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the Modified Clavien-Dindo classification. Secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.

Official Title
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Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study

Conditions
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Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Malignancy

Intervention / Treatment
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* Procedure: esophagectomy with three-field lymphnode dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus. Surgical resectable carcinoma (T1-4a, N1-3) (table 1) Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV Age ≥ 18 European Clinical Oncology Group (ECOG) performance status 0,1 or 2 Written informed consent Exclusion Criteria: Distant metastases Esophageal carcinoma < 3 cm beneath UES Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III) Former radiotherapy or chemotherapy for esophageal carcinoma Former radiotherapy precluding radiotherapy according the CROSS protocol Inadequate pulmonary function disabling transthoracic resection >10% loss of weight in the last six months Previous neck dissection New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgery<br>esophagectomy with three-field lymphnode dissection | Procedure: esophagectomy with three-field lymphnode dissection<br>* robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC) | Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages) | 5 years | 
| survival | 5 year overall- and disease free survival. | 5 years | 
| quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18) | QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18) | 10 years | 
| operation related events 1 | duration of surgery (minutes) | 5 years | 
| operation related events 2 | reason for prolongation of surgery if applicable | 5 years | 
| operation related events 3 | unexpected events/ complications | 5 years | 
| operation related events 4 | bloodloss (ml) reason for conversion if applicable. | 5 years | 
| operation related events 5 | reason for conversion if applicable. | 5 years | 
| postoperative recovery | duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days), | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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three-field lymphadenectomy, cervical metastases, esophagectomy