Radiotherapy in Primary Mediastinal Lymphoma

NCT ID: NCT01230008

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Adjuvant Radiotherapy on Complete Remission Patients

Keywords

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primary mediastinal lymphoma radiotherapy chemotherapy rituximab

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiotherapy in mediastinal lymphoma

Adjuvant radiotherapy or not (control group) in patients treated with R-CHOP

No interventions assigned to this group

Radiotherapy in mediastinal lymphoma

Radiotherapy will no be administered in patients treated with R-CHOP

No interventions assigned to this group

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.

no drugs

Intervention Type RADIATION

Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP

Interventions

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no drugs

Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP

Intervention Type RADIATION

Other Intervention Names

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no applicable

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mexican Institute of Social Security

Locations

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Oncology Research Unit

Mèxico DF, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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katt7

Identifier Type: OTHER

Identifier Source: secondary_id

katty7

Identifier Type: -

Identifier Source: org_study_id