NCT00232440

Brief Summary

Radiation therapy has a well-established role in the treatment of Hodgkin's Disease and non-Hodgkin's Lymphoma. With technological developments, 3-D Dimensional (3D) planning has evolved as a highly precise treatment planning option. High-precision radiation therapy has the potential for more accurate dose delivery to the tumour volume and can result in a greater sparing of normal tissue. An important component of safe radiotherapy delivery is the feasibility and reproducibility of current and new immobilization devices for highly conformal treatment. The purpose of this study is to determine the reproducibility of an immobilization device known as BodyFIX(TM) using conventional treatment techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 11, 2010

Status Verified

August 1, 2010

Enrollment Period

6.4 years

First QC Date

October 3, 2005

Last Update Submit

August 10, 2010

Conditions

Hodgkin's DiseaseLymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

  • The primary outcome for the study is the average deviation in set-up.

Interventions

BodyFIXDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing curative or palliative treatment in whom it is considered that immobilization of part or all of an anatomical region would be of benefit to their care.

You may not qualify if:

  • Any case where ideal treatment may be compromised with use of immobilization method.
  • If the patient has any social issues, language barriers resulting in difficulties comprehending the nature of the study, or poor performance status, that could compromise compliance with the study guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alex Sun, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

January 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 11, 2010

Record last verified: 2010-08

Locations

CA(1)