Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-11

Study Completion Date

2021-01-25

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.

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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.

Conditions

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Cancer Squamous Cell Carcinoma Adenocarcinoma Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

esophagectomy with three-field lymphnode dissection

Group Type OTHER

esophagectomy with three-field lymphnode dissection

Intervention Type PROCEDURE

robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection

Interventions

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esophagectomy with three-field lymphnode dissection

robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No