LymphomaNCT00928096
Breathing Adapted Radiotherapy for Mediastinal Lymphoma
An observational study of Lymphoma, run by Peter Meidahl Petersen at 1 site in Denmark.
Trial summary
In this study, radiation therapy plans will be made for 20 consecutive patients with mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another plan is done using the standard procedure with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas refered to Hematological Clinic, Copenhagen University Hospital, Rigshospitalet
Who may be able to join
- Stage I/II mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphomas
- Treatment plan includes radiotherapy
Who cannot join
- Not able to comply to breathing adapted therapy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hematology and Department of Radiation Oncology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, DK2100
About this study
In this study, radiation therapy plans will be made for 20 consecutive patients with mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another plan is done using the standard procedure with pre-chemo PET-CT fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.
Read the detailed description
Radiotherapy using a breathing adapted therapy scan is a routine technique in breast cancer. Breathing adapted radiotherapy may also reduce radiation dose to organs at risk, e.g. heart and lung, in patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas.
Optimal radiation therapy of these lymphoma patients includes radiotherapy planning using pre-chemotherapy PET-scanning, fused with a post-chemo planning CT-scan. This makes accurate treatment of pre-chemo involved volume possible and also accurate radiation of the post-chemo involved volume possible. Thus, the optimal breathing adapted radiation requires planning using a breathing adapted pre-chemo PET-CT scan fused with a breathing adapted post-chemo planning CT scan. In this study, 20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas will have combination therapy with chemotherapy and radiation therapy to involved nodes. Two radiation therapy plans will be made for each patient: one using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan, and one using the standard procedure of a pre-chemo PET-CT scan fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Radiotherapy, Positron-Emission Tomography, CT scan
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated radiation dose levels to the lymphoma and to the organs of risk
Measured: Before day 1 of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Meidahl Petersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Peter Meidahl Petersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Peter M Petersen, MD, Ph.D, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928096
- Sponsor's protocol ID
- HN-gating-001
- Other IDs
- H-D-2007-0069
- Status last verified
- Oct 2014
- First submitted
- 23 Jun 2009
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen PM, Aznar MC, Berthelsen AK, Loft A, Schut DA, Maraldo M, Josipovic M, Klausen TL, Andersen FL, Specht L. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma: benefit of deep inspiration breath-hold. Acta Oncol. 2015 Jan;54(1):60-6. doi: 10.3109/0284186X.2014.932435. Epub 2014 Jul 15.
PubMed 25025999
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Adapted Radiotherapy for Mediastinal Lymphoma
- ClinicalTrials.gov ID
- NCT00928096
- Acronym / sponsor ID
- HN-gating-001
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Radiotherapy, Positron-Emission Tomography, CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Peter Meidahl PetersenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jun 2009 (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.
In this study, radiation therapy plans will be made for 20 consecutive patients with mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another plan is done using the standard procedure with pre-chemo PET-CT fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.
Detailed description
Radiotherapy using a breathing adapted therapy scan is a routine technique in breast cancer. Breathing adapted radiotherapy may also reduce radiation dose to organs at risk, e.g. heart and lung, in patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas.
Optimal radiation therapy of these lymphoma patients includes radiotherapy planning using pre-chemotherapy PET-scanning, fused with a post-chemo planning CT-scan. This makes accurate treatment of pre-chemo involved volume possible and also accurate radiation of the post-chemo involved volume possible. Thus, the optimal breathing adapted radiation requires planning using a breathing adapted pre-chemo PET-CT scan fused with a breathing adapted post-chemo planning CT scan. In this study, 20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas will have combination therapy with chemotherapy and radiation therapy to involved nodes. Two radiation therapy plans will be made for each patient: one using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan, and one using the standard procedure of a pre-chemo PET-CT scan fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas refered to Hematological Clinic, Copenhagen University Hospital, Rigshospitalet
Key inclusion criteria (2 listed)
- Stage I/II mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphomas
- Treatment plan includes radiotherapy
Key exclusion criteria (1 listed)
- Not able to comply to breathing adapted therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimated radiation dose levels to the lymphoma and to the organs of risk
Time frame: Before day 1 of radiation therapy
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 21 Oct 2014.
- Results publication: PubMed 25025999Petersen PM, Aznar MC, Berthelsen AK, Loft A, Schut DA, Maraldo M, Josipovic M, Klausen TL, Andersen FL, Specht L. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma: benefit of deep inspiration breath-hold. Acta Oncol. 2015 Jan;54(1):60-6. doi: 10.3109/0284186X.2014.932435. Epub 2014 Jul 15.
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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.
Peter M Petersen, MD, Ph.D principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Lymphoma, run by Peter Meidahl Petersen at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 21 Oct 2014. 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 Denmark. 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?
Estimated radiation dose levels to the lymphoma and to the organs of risk (time frame: Before day 1 of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928096, which also lists 1 linked publication.
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 21 Oct 2014.