Radiotherapy in Primary Mediastinal Lymphoma

Adjuvant Radiotherapy on Complete Remission Patients Clinical Trial

— pml  

Official title:

Adjuvant Radiotherapy in Primary Mediastinal Lymphoma in Patients That Received R-CHOP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230008
• Other study ID #: katty7
• Secondary ID: katt7
• Status: Completed
• Phase: N/A
• First received: October 27, 2010
• Last updated: October 27, 2010
• Start date: June 2002
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mèxico: National Research Counsil, Instituto Mexicano del Seguro Social
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adjuvant Radiotherapy on Complete Remission Patients

Intervention

Radiation:
• no drugs
Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP

Locations

Country	Name	City	State
Mexico	Oncology Research Unit	Mèxico DF	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of progression free-survival and overall survival at > 5 years	Assess if the use of adjuvant radiotherapy improve outcome in patients with primary mediastinal lymphoma treated initially with R-CHOP	5 years	No
Secondary	assess toxicity secondary to mediastinal radiotherapy	Assess if the addition of mediastinal radiotherapy to patients who received anthracyclines can produce an increase in cardiac toxicity	> 5 years	No