Trial Review

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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
Sex
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
1/09/2000
Actual
15/09/2000
Date of last participant enrolment
Anticipated
Actual
28/02/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
32
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Trial website
Trial related presentations / publications
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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.