Neo-adjuvant behandling av esofagus-cardia cancer inför kurativt syftande resektion. Jämförande studie mellan kemo- och radiokemobehandling. - Neo-adjuvant behandling av esofagus-cardia cancer

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Product Name: cisplatinum Pharmaceutical Form: Intravenous infusion Product Name: 5‐Fluorouracil Pharmaceutical Form: Intravenous infusion CONDITION: 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. PRIMARY OUTCOME: Main Objective: To access whether combined radiochemoterapi will be followed by larger propotion of complite histological responses after surgical resection compared to chemotherapy alone. Primary end point(s): Complete histological respons in the resected specimen. Secondary Objective: Safety aspects; disease free survival ; crude survival; postoperativ morbidity 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
Epistemonikos ID: 05388bd4e7d4193d67fbc60f89fb3ac6f33f4145
First added on: Aug 21, 2024