Radiotherapy in Primary Mediastinal Lymphoma (pml)

October 27, 2010 updated by: Instituto Mexicano del Seguro Social

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mèxico DF, DF, Mexico, 06725
        • Oncology Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with primary mediastinal lymphoma treated in an tertiary medical center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiotherapy in mediastinal lymphoma
Adjuvant radiotherapy or not (control group) in patients treated with R-CHOP
Radiotherapy in mediastinal lymphoma
Radiotherapy will no be administered in patients treated with R-CHOP
Radiotherapy in primary mediastinal lymphoma
Patients with primary mediastinal lymphoma will be treated with R-CHOP as induction therapy, if complete response is achieved, they were allocated to received or no (control group) adjuvatn radiotherapy, 3.5 G to mediastinal site.
Radiation: no drugs
Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP
Other Names:
  • no applicable

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess toxicity secondary to mediastinal radiotherapy
Time Frame: > 5 years
Assess if the addition of mediastinal radiotherapy to patients who received anthracyclines can produce an increase in cardiac toxicity
> 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 28, 2010

Study Record Updates

Last Update Posted (Estimate)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • katty7
  • katt7 (Other Identifier: Mexican Institute of Social Security)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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