Adjuvant Radiotherapy on Complete Remission PatientspmlNCT01230008
Radiotherapy in Primary Mediastinal Lymphoma
An observational study of Adjuvant Radiotherapy on Complete Remission Patients, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adjuvant Radiotherapy on Complete Remission Patients
- What is being tested?
- no drugs
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2002to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary mediastinal lymphoma treated in an tertiary medical center
Who may be able to join
- Diagnosis of primary mediastinal lymphoma No previous treatment performance status < 2 HIV, Hepatis B and C negative Normal :Renal, hepatic, pulmonary and cardiac function
Who cannot join
- pregnancy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- no drugs
- Keywords
- primary mediastinal lymphoma, radiotherapy, chemotherapy, rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drugsRadiation
Also called no applicable
Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: no drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
assess toxicity secondary to mediastinal radiotherapy
Assess if the addition of mediastinal radiotherapy to patients who received anthracyclines can produce an increase in cardiac toxicity
Measured: > 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startJun 2002
- Primary completionJun 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjuvant Radiotherapy on Complete Remission PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230008
- Sponsor's protocol ID
- katty7
- Other IDs
- katt7
- Acronym
- pml
- Status last verified
- Jun 2009
- First submitted
- 27 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Radiotherapy in Primary Mediastinal Lymphoma in Patients That Received R-CHOP
- ClinicalTrials.gov ID
- NCT01230008
- Acronym / sponsor ID
- pml / katty7
- Keywords
- primary mediastinal lymphoma, radiotherapy, chemotherapy, rituximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Jun 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Radiation: no drugsPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary mediastinal lymphoma treated in an tertiary medical center
Key inclusion criteria (1 listed)
- Diagnosis of primary mediastinal lymphoma No previous treatment performance status < 2 HIV, Hepatis B and C negative Normal :Renal, hepatic, pulmonary and cardiac function
Key exclusion criteria (2 listed)
- pregnancy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no drugsAlso: no applicableAdjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP | Radiation | Radiotherapy in primary mediastinal lymphoma |
Primary outcome
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
1 secondary outcome
assess toxicity secondary to mediastinal radiotherapy
Time frame: > 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adjuvant Radiotherapy on Complete Remission Patients, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of progression free-survival and overall survival at > 5 years (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2010.