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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 (TROG)
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/show/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.
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
Other publications