LymphomaPhase 2NCT02803840
Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma
A Phase 2 study testing Low-dose radiotherapy in people with Lymphoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Low-dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Jun 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico
Aviano, Pordenone, 33081
Carlo Furlan, Oncologist, +390434659081, cfurlan@cro.it
Daniela Quitadamo, Biologist, +390434659077, dquitadamo@cro.it
About this study
Official title: A Phase II Trial of Low-Dose Radiotherapy for the Palliation of Patients With Diffuse Large B-cell Lymphoma
Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).
Read the detailed description
Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.
- Conditions
- Lymphoma
- Being tested
- Low-dose radiotherapy
- Keywords
- Large B-Cell, Diffuse
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose radiotherapyRadiation
Also called LDRT
2 x 2 Gy on symptomatic sites only
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Other | DLBCL patients with indication for palliative radiotherapy Receives: Radiation: Low-dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Clinical response is defined as reduction > 50% of maximum diameter of the radiated lesion
Measured: Clinical response up to 21 days after treatment
Secondary outcomes (1)
Quality of life according to the EORTC QLQ-C30 questionnaire
Measured: The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2011
- Primary completionJun 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Furlan, MD, Principal investigator, Centro di Riferimento Oncologico - Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803840
- Sponsor's protocol ID
- CRO-2011-14
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Low-Dose Radiotherapy for the Palliation of Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02803840
- Acronym / sponsor ID
- CRO-2011-14
- Conditions
- Lymphoma
- Keywords
- Large B-Cell, Diffuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Jun 2016 (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.
Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).
Detailed description
Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Radiation: Low-dose radiotherapyDLBCL patients with indication for palliative radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Low-dose radiotherapyAlso: LDRT2 x 2 Gy on symptomatic sites only | Radiation | Experimental |
Primary outcome
Response rate
Time frame: Clinical response up to 21 days after treatment
Clinical response is defined as reduction > 50% of maximum diameter of the radiated lesion
1 secondary outcome
Quality of life according to the EORTC QLQ-C30 questionnaire
Time frame: The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Carlo Furlan, MD principal investigator
Centro di Riferimento Oncologico - Aviano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose radiotherapy in people with Lymphoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Jun 2016. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Furlan, MD (+390434659081, cfurlan@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Clinical response up to 21 days after treatment). 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 17 Jun 2016; AzTrials last refreshed its copy on 31 Oct 2026.