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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00141648




Registration number
NCT00141648
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
1/10/2009

Titles & IDs
Public title
Chemotherapy and Radiotherapy for Osteolymphoma
Scientific title
A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma
Secondary ID [1] 0 0
ALLG LY-02
Secondary ID [2] 0 0
TROG 99.04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteolymphoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.
Treatment: Other - Radiotherapy

Experimental: 1 - Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.


Treatment: Drugs: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.
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

Treatment: Other: Radiotherapy
Total 45 Gy in 25 fractions
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival. The time from registration to the date of death
Timepoint [1] 0 0
Main analysis when accrual is complete at approx. 10 years.
Secondary outcome [1] 0 0
Time to local or regional failure. Measured from registration.
Timepoint [1] 0 0
Main analysis when accrual is complete at approx. 10 years.
Secondary outcome [2] 0 0
Pathological fracture rate. Measured from registration.
Timepoint [2] 0 0
Main analysis when accrual is complete at approx. 10 years.

Eligibility
Key inclusion criteria
* 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
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous radiotherapy
* Previous malignancy
* Medically unfit to undergo treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [4] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [5] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 0 0
The Wesley Radiation Oncology Pty Ltd - Auchenflower
Recruitment hospital [7] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [8] 0 0
Mater QRI - South Brisbane
Recruitment hospital [9] 0 0
North Queensland Oncology Service - Townsville
Recruitment hospital [10] 0 0
East Coast Cancer Centre, John Flynn Hospital - Tugun
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [15] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [16] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [17] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
2310 - Newcastle
Recruitment postcode(s) [4] 0 0
2145 - Wentworthville
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
4006 - Auchenflower
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4810 - Townsville
Recruitment postcode(s) [10] 0 0
4224 - Tugun
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
7000 - Hobart
Recruitment postcode(s) [14] 0 0
7250 - Launceston
Recruitment postcode(s) [15] 0 0
3002 - East Melbourne
Recruitment postcode(s) [16] 0 0
3220 - Geelong
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
New Zealand
State/province [3] 0 0
Palmerston North

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Leukaemia and Lymphoma Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australasian Radiation Oncology Lymphoma Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Wesley Research Institute
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00141648
Trial related presentations / publications
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.
Christie 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.
Christie 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.
Public notes

Contacts
Principal investigator
Name 0 0
David Christie, FRANZCR
Address 0 0
East Coasr Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00141648