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

• Conditions: 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.

• Registration Number: EUCTR2006-001785-16-SE
• Lead Sponsor: Karolinska universitetssjukhuset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-20
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>disease free survival <br>crude survival<br>postoperativ morbidity;Primary end point(s): Complete histological respons in the resected specimen.