T4 Oesophageal Resection.
Recruiting
- Conditions
- Esophageal carcinoma, Esophagectomy, Chemoradiotherapy, T4 tumor
- Registration Number
- NL-OMON25753
- Lead Sponsor
- Academic Medical Center (AMC), Department of Surgery
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ability to achieve a radical (R0) resection.
- Secondary Outcome Measures
Name Time Method 1. Toxicity profile of chemoradiotherapy;<br /><br>2. Adequacy of PET-CT and EUS in (re)staging T4 esophageal carcinoma;<br /><br>3. Peri-operative morbidity and mortality;<br /><br>4. Percentage of pathologic complete response;<br /><br>5. Progression free survival at 6 months.