ode study: 'Esophageal resection for patients with esophageal cancer and cervical lymph node metastases'
- Conditions
- esophageal cancer with cervical lymphnode metastasis100179901001799110017998
- Registration Number
- NL-OMON44167
- Lead Sponsor
- Heelkunde, chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
- Histologically proven squamous cell carcinoma or adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
- Surgical resectable carcinoma (T1-4a, N1-3)
- 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
- 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
- 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is the percentage of overall postoperative complications grade<br /><br>3b and higher as stated by the modified Clavien-Dindo classification (MCDC).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are individual components of the primary outcome,<br /><br>complications grade 2 and 3a, mortality, operation related events and<br /><br>postoperative recovery including quality of life, disease free survival, 5 year<br /><br>overall survival and if applicable location of recurrent disease.</p><br>