NCT02426879

Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Squamous Cell Carcinoma
• Adenocarcinoma
• Malignancy

Interventions

Type	Name	Description
PROCEDURE	esophagectomy with three-field lymphnode dissection	robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection

Timeline

• Start date: 2015-02-11
• Primary completion: 2021-01-25
• Completion: 2021-01-25
• First posted: 2015-04-27
• Last updated: 2021-09-30

Locations

1 site across 1 country: Netherlands