Status:
UNKNOWN
Efficacy and Safety Study of the Combined Modality Therapy in Adenocarcinoma of the Esophago-gastric Junction
Lead Sponsor:
Medical University of Lublin
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The high cancer related mortality has remained a significant issue of health care in Poland, Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a marked trend ...
Detailed Description
Adenocarcinoma of the esophago-gastric junction (AEG) represents an aggressive disease with poor prognosis. Surgery is the traditional mainstay of treatment for patients presenting with locally advanc...
Eligibility Criteria
Inclusion
- patients of both gender, aged more than 18, with histopathologically confirmed adenocarcinoma of the esophagogastric junction
- medically fit to undergo a major surgery with planned thoracotomy and in general condition allowing to tolerate chemo- or chemoradiotherapy (Karnofsky Performance Status ≥70, ECOG 0-1).
- Carcinoma of the esophagogastric junction defined as adenocarcinoma involving esophagogastric junction when its epicenter is localized within 5cm proximally or 5cm distally to the anatomical esophagogastric junction with subclassification to 3 topographic types (type I between 5cm and 1cm above; type II between 1cm above and 2cm below; type III between 2cm and 5cm below anatomic junction of the esophagus and the stomach).
- Potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0.
- The intended number of randomized patients has been set as 100: 50 patients randomized to each therapeutic arm with assumption, that 80% of randomized patients will complete the treatment protocol.
Exclusion
- disseminated cancer
- poor general condition (KI \<70)
- adenocarcinoma of the stomach
- adenocarcinoma of the esophagus
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01523015
Start Date
January 1 2012
End Date
December 1 2020
Last Update
February 5 2013
Active Locations (1)
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1
Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
Lublin, Lublin Voivodeship, Poland, 20-081