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Trial registered on ANZCTR


Registration number
ACTRN12607000111471
Ethics application status
Approved
Date submitted
22/12/2003
Date registered
22/12/2003
Date last updated
27/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, non-randomised study of chemotherapy and radiotherapy for osteolymphoma (OL)
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 99.04 - A prospective, non-randomised study of chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisolone) and radiotherapy for osteolymphoma (OL) to determine the outcome of optimal treatment on low grade follicular lymphoma progression.
Secondary ID [1] 69 0
National Clinical Trials Registry: NCTR473
Secondary ID [2] 70 0
ClinicalTrials.gov: NCT00141648
Secondary ID [3] 71 0
The Australasian Leukaemia and Lymphoma Group: ALLG LY-02
Universal Trial Number (UTN)
Trial acronym
TROG 99.04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteolymphoma 45 0
Condition category
Condition code
Cancer 52 52 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chemotherapy
Given Intravenously on days 1, 22, 43:
- Cyclophosphamide 750 mg per metre squared
- Doxorubicin 50 mg per metre squared
- Vincristine 1.4mg per metre squared
Prednisolone 50 mg per metre squared. Given orally for five days on each of these occassions. ie days 1-5, 22-27 etc.
A total of three 21 day cycles of chemotherapy should be administered.

Radiotherapy
should be given 3 weeks after the last cycle of chemotherapy (day 64).
Fractions should be given daily - 9-10 times per fortnight. Phase I (large volume): 36Gy in 20 fractions and Phase II (small volume): 9 GY in 5 fractions to the boost volume (area of tumour that requires a boost of radiotherapy). Total dose 45 Gy in 25 fractions. Phase I and II are given over the course of one fortnight.
Intervention code [1] 1499 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 3381 0
Overall Survival.
Timepoint [1] 3381 0
Main analysis when accrual is complete at approx. 10 years.
Secondary outcome [1] 211 0
1.Tumor progression. Defined as an increase in diameter for solitary lesions, multifocal disease or any new lesion.
Timepoint [1] 211 0
Formal assessment will be done four weeks after completion of the radiotherapy. Follow-up thereafter should consist of three-monthly appointments with repetition of individually-selected imaging at six months. After 18 months, follow-up will reduce to six-monthly without imaging, and from five years, annual follow-up without imaging until death.
Secondary outcome [2] 212 0
2. Pathological fracture rate. Presence of a pathological fracture.
Timepoint [2] 212 0
Formal assessment will be done four weeks after completion of the radiotherapy. Follow-up thereafter should consist of three-monthly appointments with repetition of individually-selected imaging at six months. After 18 months, follow-up will reduce to six-monthly without imaging, and from five years, annual follow-up without imaging until death.
Secondary outcome [3] 213 0
3. Toxicity.
Timepoint [3] 213 0
Formal assessment will be done four weeks after completion of the radiotherapy. Follow-up thereafter should consist of three-monthly appointments with repetition of individually-selected imaging at six months. After 18 months, follow-up will reduce to six-monthly without imaging, and from five years, annual follow-up without imaging until death.

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 - 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 or chemotherapy- 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
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment hospital [1] 4751 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 4752 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 4753 0
Westmead Private Hospital - Westmead
Recruitment hospital [4] 4754 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 4755 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 4756 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 4757 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [8] 4758 0
Mater Adult Hospital - South Brisbane
Recruitment outside Australia
Country [1] 7382 0
New Zealand
State/province [1] 7382 0

Funding & Sponsors
Funding source category [1] 74 0
Commercial sector/Industry
Name [1] 74 0
Wesley Research Institute
Address [1] 74 0
Level B2, Moorlands Wing
The Wesley Hospital
451 Coronation Drive
Auchenflower
Qld 4066
Country [1] 74 0
Australia
Primary sponsor type
Individual
Name
David Christie
Address
East Coast Cancer Centre Inland Drive, Tugun QLD 4224
Country
Australia
Secondary sponsor category [1] 60 0
Other Collaborative groups
Name [1] 60 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 60 0
Edith St Waratah NSW 2298
Country [1] 60 0
Australia
Secondary sponsor category [2] 61 0
Other Collaborative groups
Name [2] 61 0
The Australasian Leukaemia and Lymphoma Group (ALLG)
Address [2] 61 0
Peter MacCallum Cancer Centre
St Andrew's Place
East Melbourne
Victoria 3002
Country [2] 61 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 721 0
Auckland Hospital
Ethics committee address [1] 721 0
Auckland, NZ
Ethics committee country [1] 721 0
New Zealand
Date submitted for ethics approval [1] 721 0
Approval date [1] 721 0
01/01/2001
Ethics approval number [1] 721 0
Ethics committee name [2] 722 0
Geelong Hospital
Ethics committee address [2] 722 0
Geelong, VIC
Ethics committee country [2] 722 0
Australia
Date submitted for ethics approval [2] 722 0
Approval date [2] 722 0
Ethics approval number [2] 722 0
Ethics committee name [3] 723 0
John Flynn Hospital
Ethics committee address [3] 723 0
Ethics committee country [3] 723 0
Australia
Date submitted for ethics approval [3] 723 0
Approval date [3] 723 0
Ethics approval number [3] 723 0
Ethics committee name [4] 724 0
Launceston Hospital
Ethics committee address [4] 724 0
Lanuceston, TAS
Ethics committee country [4] 724 0
Australia
Date submitted for ethics approval [4] 724 0
Approval date [4] 724 0
Ethics approval number [4] 724 0
Ethics committee name [5] 725 0
Liverpool Hospital
Ethics committee address [5] 725 0
Liverpool, NSW
Ethics committee country [5] 725 0
Australia
Date submitted for ethics approval [5] 725 0
Approval date [5] 725 0
Ethics approval number [5] 725 0
Ethics committee name [6] 726 0
Calvary Mater Newcastle
Ethics committee address [6] 726 0
Waratah, NSW
Ethics committee country [6] 726 0
Australia
Date submitted for ethics approval [6] 726 0
Approval date [6] 726 0
Ethics approval number [6] 726 0
Ethics committee name [7] 727 0
Princess Alexandra Hospital
Ethics committee address [7] 727 0
Wooloongabba, QLD
Ethics committee country [7] 727 0
Australia
Date submitted for ethics approval [7] 727 0
Approval date [7] 727 0
Ethics approval number [7] 727 0
Ethics committee name [8] 728 0
Palmerston North
Ethics committee address [8] 728 0
Papaioea, Manawatu-Wanganui, NZ
Ethics committee country [8] 728 0
New Zealand
Date submitted for ethics approval [8] 728 0
Approval date [8] 728 0
Ethics approval number [8] 728 0
Ethics committee name [9] 729 0
Peter MacCallum Cancer Centre
Ethics committee address [9] 729 0
Melbourne, VIC
Ethics committee country [9] 729 0
Australia
Date submitted for ethics approval [9] 729 0
Approval date [9] 729 0
Ethics approval number [9] 729 0
Ethics committee name [10] 730 0
Mater Centre, QRI
Ethics committee address [10] 730 0
South Brisbane, QLD
Ethics committee country [10] 730 0
Australia
Date submitted for ethics approval [10] 730 0
Approval date [10] 730 0
Ethics approval number [10] 730 0
Ethics committee name [11] 731 0
Royal Adelaide Hospital
Ethics committee address [11] 731 0
Aelaide, SA
Ethics committee country [11] 731 0
Australia
Date submitted for ethics approval [11] 731 0
Approval date [11] 731 0
Ethics approval number [11] 731 0
Ethics committee name [12] 732 0
Royal Brisbane Hospital
Ethics committee address [12] 732 0
Brisbane, QLD
Ethics committee country [12] 732 0
Australia
Date submitted for ethics approval [12] 732 0
Approval date [12] 732 0
Ethics approval number [12] 732 0
Ethics committee name [13] 733 0
Royal Hobart Hospital
Ethics committee address [13] 733 0
Hobart, TAS
Ethics committee country [13] 733 0
Australia
Date submitted for ethics approval [13] 733 0
Approval date [13] 733 0
Ethics approval number [13] 733 0
Ethics committee name [14] 734 0
Royal Prince Alfred Hospital
Ethics committee address [14] 734 0
Camperdown, NSW
Ethics committee country [14] 734 0
Australia
Date submitted for ethics approval [14] 734 0
Approval date [14] 734 0
Ethics approval number [14] 734 0
Ethics committee name [15] 735 0
Sir Charles Gairdner Hospital
Ethics committee address [15] 735 0
Nedlands, WA
Ethics committee country [15] 735 0
Australia
Date submitted for ethics approval [15] 735 0
Approval date [15] 735 0
Ethics approval number [15] 735 0
Ethics committee name [16] 736 0
Townsville Hospital
Ethics committee address [16] 736 0
Townsville, QLD
Ethics committee country [16] 736 0
Australia
Date submitted for ethics approval [16] 736 0
Approval date [16] 736 0
Ethics approval number [16] 736 0
Ethics committee name [17] 737 0
Waikato Hospital
Ethics committee address [17] 737 0
Hamilton, NZ
Ethics committee country [17] 737 0
New Zealand
Date submitted for ethics approval [17] 737 0
Approval date [17] 737 0
Ethics approval number [17] 737 0
Ethics committee name [18] 738 0
Westmead Hospital
Ethics committee address [18] 738 0
Wentworthville, NSW
Ethics committee country [18] 738 0
Australia
Date submitted for ethics approval [18] 738 0
Approval date [18] 738 0
Ethics approval number [18] 738 0
Ethics committee name [19] 739 0
Premion - Wesley
Ethics committee address [19] 739 0
Auchenflower, QLD
Ethics committee country [19] 739 0
Australia
Date submitted for ethics approval [19] 739 0
Approval date [19] 739 0
Ethics approval number [19] 739 0
Ethics committee name [20] 740 0
Wollongong Hospital
Ethics committee address [20] 740 0
Wollongong, NSW
Ethics committee country [20] 740 0
Australia
Date submitted for ethics approval [20] 740 0
Approval date [20] 740 0
Ethics approval number [20] 740 0

Summary
Brief summary
Osteolymphoma is a cancer of the bone marrow that responds well to radiation therapy and chemotherapy but may come back in other parts of the body. This trial will determine the results of combining radiation therapy and chemotherapy in a standardised way.
Trial website
Trial related presentations / publications
Christie DR, Gabriel GS and 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? J Intern Med. 2007; 37: 680-686.

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 Imag Radiat Oncol. 2009; 53 (2): 203–206.

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 Leukemia and Lymphoma Group LY02 Prospective Trial. Int J Radiat Oncol Biol Phys. 2011; 80 (4):1164-1170.
Public notes

Contacts
Principal investigator
Name 27433 0
Prof David Christie
Address 27433 0
East Coast Cancer Centre Inland Drive, Tugun QLD 4224
Country 27433 0
Australia
Phone 27433 0
+61 2 4014 3912
Fax 27433 0
Email 27433 0
dchristie@wesley.com.au
Contact person for public queries
Name 10688 0
Mr Thai Le
Address 10688 0
The Wesley Radiation Oncology Pty Ltd
Suite 1
40 Chasely Street
Auchenflower QLD 4066
Country 10688 0
Australia
Phone 10688 0
+61 7 3326 9505
Fax 10688 0
+61 7 3326 9506
Email 10688 0
Thaile@wesley.com.au
Contact person for scientific queries
Name 1616 0
Prof David Christie
Address 1616 0
East Coast Cancer Centre
Inland Drive, Tugun QLD 4224
Country 1616 0
Australia
Phone 1616 0
+61 7 5598 0366
Fax 1616 0
+61 7 5598 0377
Email 1616 0
dchristie@wesley.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary