Esophageal carcinoma, Esophagectomy, Chemoradiotherapy, T4 tumor
Conditions
Interventions
Surgery after chemoradiotherapy: Transthoracic esophagal resection (open, right thoracotomy) with en-bloc two-field lymphadenectomy.
Sponsors
Academic Medical Center (AMC), Department of Surgery
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastroesophageal junction; 2. Surgically irresectable T4 carcinoma as determined by endoscopic ultrasonography (EUS), CT scan or PET-CT of neck, thorax and abdomen, without distant mestastases.
Exclusion criteria
Exclusion criteria: 1. cT4 carcinoma with tracheobronchial involvement demonstrated on bronchoscopy after chemoradiotherapy; 2. Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment; 3. Pregnancy (positive serum pregnancy test) and lactation; 4. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 15%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ability to achieve a radical (R0) resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity profile of chemoradiotherapy; 2. Adequacy of PET-CT and EUS in (re)staging T4 esophageal carcinoma; 3. Peri-operative morbidity and mortality; 4. Percentage of pathologic complete response; 5. Progression free survival at 6 months. | — |
Contacts
Public ContactR.L.G.M. Blom
Postbus 4446
Outcome results
None listed