Breathing Adapted Radiotherapy for Mediastinal Lymphoma | NCT00928096

Studies
Breathing Adapted Radiotherapy for Mediastinal Lymphoma

NCT00928096

Sponsor

Peter Meidahl Petersen

Status

Completed

Last Update Posted

Oct 21, 2014Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Lymphoma

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-D-2007-0069

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jun 23, 2009

First Submission Date that Met QC Criteria

Jun 24, 2009

First Posted Date

Jun 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2014

Last Update Posted Date

Oct 21, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Meidahl Petersen, MD.Ph.D, Rigshospitalet, Denmark, Rigshospitalet, DenmarkSponsor-Investigator

Lead Sponsor

Peter Meidahl PetersenOTHER

Collaborators

Name	Class
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimated radiation dose levels to the lymphoma and to the organs of risk		Before day 1 of radiation therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter M Petersen, MD, Ph.D	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematology and Department of Radiation Oncology, Copenhagen University Hospital, Rigshospitalet		Copenhagen		DK2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25025999	Result	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.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases