Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

Not Applicable

Completed

• Conditions: Malignancy; Adenocarcinoma; Cancer; Squamous Cell Carcinoma
• Interventions: Procedure: esophagectomy with three-field lymphnode dissection

• Registration Number: NCT02426879
• Lead Sponsor: UMC Utrecht

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02-11
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-27
• Primary Completion: 2021-01-25
• Study Completion: 2021-01-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgery	esophagectomy with three-field lymphnode dissection	esophagectomy with three-field lymphnode dissection

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands