Clinical trial NCT02426879: Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
Official title: Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Squamous Cell Carcinoma
Adenocarcinoma
Malignancy
Keywords: three-field lymphadenectomy
cervical metastases
esophagectomy
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
timeFrame: 5 years
Secondary outcomes:
measure: mortality
timeFrame: 5 years
measure: survival
timeFrame: 5 years
measure: quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
timeFrame: 10 years
measure: operation related events 1
timeFrame: 5 years
measure: operation related events 2
timeFrame: 5 years
measure: operation related events 3
timeFrame: 5 years
measure: operation related events 4
timeFrame: 5 years
measure: operation related events 5
timeFrame: 5 years
measure: postoperative recovery
timeFrame: 5 years
Other outcomes:
measure: pathology results 1
timeFrame: 5 years
measure: pathology results 2
timeFrame: 5 years
measure: pathology results 3
timeFrame: 5 years
measure: pathology results 4
timeFrame: 5 years
measure: pathology results 5
timeFrame: 5 years
measure: pathology results 6
timeFrame: 5 years
measure: pathology results 7
timeFrame: 5 years
measure: pathology results 8
timeFrame: 5 years
measure: pathology results 9
timeFrame: 5 years
measure: pathology results 10
timeFrame: 5 years
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMCU
name: Richard V Hillegersberg, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: