Breathing Adapted Radiotherapy for Mediastinal Lymphoma

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Peter Meidahl Petersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00928096
First received: June 23, 2009
Last updated: October 18, 2014
Last verified: October 2014

June 23, 2009
October 18, 2014
June 2009
May 2013   (final data collection date for primary outcome measure)
Estimated radiation dose levels to the lymphoma and to the organs of risk [ Time Frame: Before day 1 of radiation therapy ] [ Designated as safety issue: No ]
Estimated radiation dose levels to the lymphoma and to the organs of risk [ Time Frame: Before treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00928096 on ClinicalTrials.gov Archive Site
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Breathing Adapted Radiotherapy for Mediastinal Lymphoma
Breathing Adapted Radiotherapy for Mediastinal Lymphoma

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas refered to Hematological Clinic, Copenhagen University Hospital, Rigshospitalet

Lymphoma
Not Provided
Not Provided
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. 2014 Jul 15:1-7. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage I/II mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphomas
  • Treatment plan includes radiotherapy

Exclusion Criteria:

  • Not able to comply to breathing adapted therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00928096
HN-gating-001, H-D-2007-0069
No
Peter Meidahl Petersen, Rigshospitalet, Denmark
Peter Meidahl Petersen
University of Copenhagen
Principal Investigator: Peter M Petersen, MD, Ph.D Rigshospitalet, Denmark
Rigshospitalet, Denmark
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP