Breathing Adapted Radiotherapy for Mediastinal Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00928096
First received: June 23, 2009
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

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.


Condition
Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breathing Adapted Radiotherapy for Mediastinal Lymphoma

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928096

Contacts
Contact: Peter M Petersen, MD, Ph.D 45 3545 5073 peter.meidahl.petersen@rh.regionh.dk
Contact: Lena Specht, MD, DMSc +45 3545 3969 lena.specht@rh.regionh.dk

Locations
Denmark
Department of Hematology and Department of Radiation Oncology, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark, DK2100
Contact: Peter M Petersen, MD, Ph.D    +45 3545 5073    peter.meidahl.petersen@rh.regionh.dk   
Contact: Lena Specht, MD, DMSc    +45 3545 3969    lena.specht@rh.regionh.dk   
Principal Investigator: Peter M Petersen, MD PH.D         
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Investigators
Principal Investigator: Peter M Petersen, MD, Ph.D Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Peter Meidahl Petersen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00928096     History of Changes
Other Study ID Numbers: HN-gating-001, H-D-2007-0069
Study First Received: June 23, 2009
Last Updated: August 16, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Lymphoma
Radiotherapy
Positron-Emission Tomography
CT scan

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014