Radiotherapy in Primary Mediastinal Lymphoma (pml)
This study has been completed.
Sponsor:
Instituto Mexicano del Seguro Social
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
-
Contacts and Locations 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 June 17, 2013