Breathing Adapted Radiotherapy for Mediastinal Lymphoma

Lymphoma Clinical Trial

Official title:

Breathing Adapted Radiotherapy for Mediastinal Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928096
• Other study ID #: HN-gating-001
• Secondary ID: H-D-2007-0069
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: October 18, 2014
• Start date: June 2009
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
Denmark	Department of Hematology and Department of Radiation Oncology, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Peter Meidahl Petersen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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;5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated radiation dose levels to the lymphoma and to the organs of risk		Before day 1 of radiation therapy	No