Radiotherapy in Primary Mediastinal Lymphoma

Completed

• Conditions: Adjuvant Radiotherapy on Complete Remission Patients

• Registration Number: NCT01230008
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

The use of Rituximab has been proposed to be useful and avoid the use of radiotherapy in diffuse large B-cell lymphoma with bulky disease.We assess efficacy of adjuvant radiotherapy in patients treated with R-CHOP

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2007-06
• Status Verified: 2009-06
• Study Completion: 2009-12
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Last Update Submitted: 2010-10-27
• Study First Posted: 2010-10-28
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Diagnosis of primary mediastinal lymphoma No previous treatment performance status < 2 HIV, Hepatis B and C negative Normal :Renal, hepatic, pulmonary and cardiac function

Exclusion Criteria

pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measurement of progression free-survival and overall survival at > 5 years	5 years	Assess if the use of adjuvant radiotherapy improve outcome in patients with primary mediastinal lymphoma treated initially with R-CHOP

Secondary Outcome Measures

Name	Time	Method
assess toxicity secondary to mediastinal radiotherapy	> 5 years	Assess if the addition of mediastinal radiotherapy to patients who received anthracyclines can produce an increase in cardiac toxicity

Trial Locations

Locations (1)

Oncology Research Unit; 🇲🇽 Mèxico DF, DF, Mexico