NCT00928096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

3.9 years

First QC Date

June 23, 2009

Last Update Submit

October 18, 2014

Conditions

Lymphoma

Keywords

LymphomaRadiotherapyPositron-Emission TomographyCT scan

Outcome Measures

Primary Outcomes (1)

  • Estimated radiation dose levels to the lymphoma and to the organs of risk

    Before day 1 of radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Not able to comply to breathing adapted therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology and Department of Radiation Oncology, Copenhagen University Hospital, Rigshospitalet

Copenhagen, DK2100, Denmark

Location

Related 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;54(1):60-6. doi: 10.3109/0284186X.2014.932435. Epub 2014 Jul 15.

    PMID: 25025999RESULT

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Peter M Petersen, MD, Ph.D

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD.Ph.D, Rigshospitalet, Denmark

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

DK(1)