Lymphoma, Low-GradePhase 3NCT00536458
Treatment of Localized Low Grade Lymphomas
A Phase 3 study testing radiotherapy and MINI CHEP in people with Lymphoma, Low-Grade, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lymphoma, Low-Grade
- What is being tested?
- radiotherapy and MINI CHEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- Mar 1999to Dec 2006
- Phase
- Phase 3
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low grade lymphoma defined according to the Ann Arbor classification
- localized
Who cannot join
- Subjects unable to signed informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie
To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma
Read the detailed description
The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients .
No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult patients
- Conditions
- Lymphoma, Low-Grade
- Being tested
- radiotherapy, MINI CHEP
- Keywords
- localized low grade lymphoma, Chemotherapy, Radiotherapy, Molecular analyses, primary
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyProcedure or surgery
mini chep+ radiotherapy
MINI CHEPDrug
chemotherapy minichep 6 courses
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy | Experimental | minichep + radiotherapy Receives: Procedure: radiotherapy |
| B | Active comparator | MINI CHEP Receives: Drug: MINI CHEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure free survival at 5 years
Measured: 5 years
Secondary outcomes (3)
overall survival at 5 years
Measured: 5 years
response rates at the end of the treatment
Measured: 6 months
prognstic value of molecular analyses in blood and marrow
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startMar 1999
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Low-GradeStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Investigators
- eric DECONINCK, MD PhD, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536458
- Sponsor's protocol ID
- 01 02
- Other IDs
- GOELAMS 01 02, GOELNH LOGLOC
- Status last verified
- Sep 2007
- First submitted
- 26 Sep 2007
- Last updated
- 1 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie
- ClinicalTrials.gov ID
- NCT00536458
- Acronym / sponsor ID
- 01 02
- Conditions
- Lymphoma, Low-Grade
- Keywords
- localized low grade lymphoma, Chemotherapy, Radiotherapy, Molecular analyses, primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- Mar 1999
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Sep 2007 (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.
To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma
Detailed description
The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients .
No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy | Experimental | Procedure: radiotherapyminichep + radiotherapy |
| B | Active comparator | Drug: MINI CHEPMINI CHEP |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low grade lymphoma defined according to the Ann Arbor classification
- localized
Key exclusion criteria (2 listed)
- Subjects unable to signed informed consent
- 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 |
|---|---|---|
| radiotherapymini chep+ radiotherapy | Procedure or surgery | radiotherapy |
| MINI CHEPchemotherapy minichep 6 courses | Drug | B |
Primary outcome
failure free survival at 5 years
Time frame: 5 years
3 secondary outcomes
overall survival at 5 years
Time frame: 5 years
response rates at the end of the treatment
Time frame: 6 months
prognstic value of molecular analyses in blood and marrow
Time frame: 6 months
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 1 Nov 2007.
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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.
eric DECONINCK, MD PhD principal investigator
French Innovative Leukemia Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiotherapy and MINI CHEP in people with Lymphoma, Low-Grade, run by French Innovative Leukemia Organisation at 1 site in France.
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 2 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 1 Nov 2007. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
failure free 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 1 Nov 2007.