Chemotherapy and Radiotherapy for Osteolymphoma
A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma
2 other identifiers
interventional
70
2 countries
20
Brief Summary
This trial is intended to determine the results obtained when standard treatment for Non Hodgkin's lymphoma is applied to the disease in a rare subtype which arises in bone. Patients in the study undergo a detailed assessment, then treatment with chemotherapy and radiotherapy, followed by close monitoring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2000
Longer than P75 for not_applicable
20 active sites
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
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedOctober 1, 2009
September 1, 2009
6.4 years
August 30, 2005
September 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival. The time from registration to the date of death
Main analysis when accrual is complete at approx. 10 years.
Secondary Outcomes (2)
Time to local or regional failure. Measured from registration.
Main analysis when accrual is complete at approx. 10 years.
Pathological fracture rate. Measured from registration.
Main analysis when accrual is complete at approx. 10 years.
Study Arms (1)
1
EXPERIMENTALChemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.
Interventions
Given intravenously on days 1,11,43: Cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, vincristine 1.4mg/m2. Given orally on days 1-5,22-27: Pednisolone 50mg/m2
Eligibility Criteria
You may qualify if:
- Histologically confirmed non-Hodgkin's lymphoma in a bony site
- Limited extraosseous disease
- Ann Arbor stage IE
- Age \>17
- ECOG performance status \<3
- Expected survival \> 6 months
- Patients capable of childbearing are using adequate contraception.
- Written informed consent
You may not qualify if:
- Previous radiotherapy
- Previous malignancy
- Medically unfit to undergo treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trans Tasman Radiation Oncology Grouplead
- Australasian Leukaemia and Lymphoma Groupcollaborator
- Australasian Radiation Oncology Lymphoma Groupcollaborator
- Wesley Research Institutecollaborator
Study Sites (20)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2310, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
The Wesley Radiation Oncology Pty Ltd
Auchenflower, Queensland, 4006, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Mater QRI
South Brisbane, Queensland, 4101, Australia
North Queensland Oncology Service
Townsville, Queensland, 4810, Australia
East Coast Cancer Centre, John Flynn Hospital
Tugun, Queensland, 4224, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Auckland Hospital
Auckland, 1001, New Zealand
Waikato Hospital
Hamilton, 3200, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Related Publications (3)
Christie DR, Gabriel GS, Dear K. Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting? Intern Med J. 2007 Oct;37(10):680-6. doi: 10.1111/j.1445-5994.2007.01451.x.
PMID: 17894765BACKGROUNDChristie D, Le T, Watling K, Cornes D, O'Brien P, Hitchins R. Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02). J Med Imaging Radiat Oncol. 2009 Apr;53(2):203-6. doi: 10.1111/j.1754-9485.2009.02054.x.
PMID: 19527368RESULTChristie D, Dear K, Le T, Barton M, Wirth A, Porter D, Roos D, Pratt G. Limited chemotherapy and shrinking field radiotherapy for Osteolymphoma (primary bone lymphoma): results from the trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 prospective trial. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1164-70. doi: 10.1016/j.ijrobp.2010.03.036. Epub 2010 Jul 16.
PMID: 20638196DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Christie, FRANZCR
East Coasr Cancer Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
September 1, 2000
Primary Completion
February 1, 2007
Study Completion
February 1, 2008
Last Updated
October 1, 2009
Record last verified: 2009-09