Immediate tumor resection in patients with locally advanced gastroesophageal adenocarcinoma with nonresponse to chemotherapy after 4 weeks of treatment versus resection after completion of chemotherapy - A randomized controlled pilottrial (Optitreat)
Not Applicable
Recruiting
- Conditions
- C15C16Malignant neoplasm of oesophagusMalignant neoplasm of stomach
- Registration Number
- DRKS00004668
- Lead Sponsor
- niversitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
• histologically proven adenocarcinoma of the esophagus or stomach
• clinical staging cT3/4 and/or cN+
• Resectable primary tumor
• Patient considered to tolerate surgery including abdominothoracic resection
(Karnofsky >80%)
• = 18 years of age
• Written informed consent
Exclusion Criteria
• Lack of understanding or language problems
• expected lack of compliance
• Patients not eligible for surgery (ASA = IV)
• distant metastases (M1) without possibility of complete resection (R0)
• neoadjuvant radiochemotherapy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate (pathological report, after surgery)
- Secondary Outcome Measures
Name Time Method Overall survival (Follow-up by phone: every 3 months during the first year, every 6 months during the second year and once a year or until death)<br>perioperative morbidity and mortality (clinical report after demission)<br>Quality of life (questionnaire, screening visit, before operation, 12 months after surgery)<br>Cost savings (after termination of therapy)<br>