Clinical trial · Interventional
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| esophagectomy with three-field lymphnode dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- surgery
- description
- esophagectomy with three-field lymphnode dissection
- interventionNames
- Procedure: esophagectomy with three-field lymphnode dissection
Primary outcomes (1)
- 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
- description
- Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
Secondary outcomes (9)
- measure
- mortality
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDvan der Horst S, Weijs TJ, Braunius WW, Mook S, Mohammed NH, Brosens L, van Rossum PSN, Weusten BLAM, Ruurda JP, van Hillegersberg R. Safety and Feasibility of Robot-Assisted Minimally Invasive Esophagectomy (RAMIE) with Three-Field Lymphadenectomy and Neoadjuvant Chemoradiotherapy in Patients with Resectable Esophageal Cancer and Cervical Lymph Node Metastasis. Ann Surg Oncol. 2023 May;30(5):2743-2752. doi: 10.1245/s10434-022-12996-x. Epub 2023 Jan 27. PMID 36707482