Cancer of the esophagus or gastricardia concidered to be resectable at the preoperative evaluation. The following TN stages will be enrolled: T1-3, N1, T2-3N0 and T2-3N1.
Conditions
Interventions
Product Name: cisplatinum
Pharmaceutical Form: Intravenous infusion
Product Name: 5-Fluorouracil
Pharmaceutical Form: Intravenous infusion
Sponsors
Karolinska universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a resectable carcinoma of the esophagus and or gastric cardia. Patients with proximal tumour localision will not be included if laryngectomy is required. Patients will be randomised to either chemoteraphy alone or combined radiochemoteraphy provided that no contraindications are privaling relevant to respecitve chemoradiotherapeutic agents. Al patients will subsequently be operated in high volume centres. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not recectable disease stages Inoperable patients due to complicating medical disorders Predictable inability to cope with the neoadjuvant treatment Unwillingnes to participate Childbearing age Predicted uncompliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To access whether combined radiochemoterapi will be followed by larger propotion of complite histological responses after surgical resection compared to chemotherapy alone.;Secondary Objective: Safety aspects disease free survival crude survival postoperativ morbidity;Primary end point(s): Complete histological respons in the resected specimen. | — |
Countries
Sweden
Outcome results
None listed