NCT01230008

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
Last Updated

October 28, 2010

Status Verified

June 1, 2009

Enrollment Period

5 years

First QC Date

October 27, 2010

Last Update Submit

October 27, 2010

Conditions

Adjuvant Radiotherapy on Complete Remission Patients

Keywords

primary mediastinal lymphomaradiotherapychemotherapyrituximab

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • assess toxicity secondary to mediastinal radiotherapy

    > 5 years

Study Arms (3)

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

Interventions

no drugsRADIATION

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

Also known as: no applicable
Radiotherapy in primary mediastinal lymphoma

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with primary mediastinal lymphoma treated in an tertiary medical center

You may qualify if:

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

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Research Unit

Mèxico DF, Mexico City, 06725, Mexico

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 28, 2010

Study Start

June 1, 2002

Primary Completion

June 1, 2007

Study Completion

December 1, 2009

Last Updated

October 28, 2010

Record last verified: 2009-06

Locations

ME(1)