Radiotherapy in Primary Mediastinal Lymphoma (pml)

This study has been completed.
Sponsor:
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01230008
First received: October 27, 2010
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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


Condition Intervention
Adjuvant Radiotherapy on Complete Remission Patients
Radiation: no drugs

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adjuvant Radiotherapy in Primary Mediastinal Lymphoma in Patients That Received R-CHOP

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • measurement of progression free-survival and overall survival at > 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assess if the use of adjuvant radiotherapy improve outcome in patients with primary mediastinal lymphoma treated initially with R-CHOP


Secondary Outcome Measures:
  • assess toxicity secondary to mediastinal radiotherapy [ Time Frame: > 5 years ] [ Designated as safety issue: No ]
    Assess if the addition of mediastinal radiotherapy to patients who received anthracyclines can produce an increase in cardiac toxicity


Enrollment: 198
Study Start Date: June 2002
Study Completion Date: December 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: no applicable

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with primary mediastinal lymphoma treated in an tertiary medical center

Criteria

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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230008

Locations
Mexico
Oncology Research Unit
Mèxico DF, DF, Mexico, 06725
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: Agustin Aviles, Mexican Institute of Social Security
ClinicalTrials.gov Identifier: NCT01230008     History of Changes
Other Study ID Numbers: katty7, katt7
Study First Received: October 27, 2010
Last Updated: October 27, 2010
Health Authority: Mèxico: National Research Counsil, Instituto Mexicano del Seguro Social

Keywords provided by Instituto Mexicano del Seguro Social:
primary mediastinal lymphoma
radiotherapy
chemotherapy
rituximab

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014