Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000073606
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
4/08/2005
Date last updated
4/08/2023
Date data sharing statement initially provided
17/02/2021
Date results information initially provided
17/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A non-randomised trial evaluating in-field control following the addition of involved-field radiotherapy to transplantation for patients with Hodgkins Disease and non-Hodgkins Lymphoma: An ALLG/TROG Prospective Multicentre Study
Scientific title
A non-randomised trial evaluating in-field control following the addition of involved-field radiotherapy to transplantation for patients with Hodgkin's Disease and non-Hodgkin's Lymphoma: An ALLG/TROG Prospective Multicentre Study
Secondary ID [1] 100 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG HDNHL4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin's disease 147 0
Non-Hodgkins lymphoma 148 0
Condition category
Condition code
Cancer 166 166 0 0
Hodgkin's
Cancer 167 167 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective non randomised trial evaluating the rate of in-field failure in patients having protocol radiotherapy with transplantation for Hodgkin's and non-Hodgkin's lymphoma.
Intervention code [1] 116 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 206 0
Determine the cumulative incidence of progression in irradiated pre-transplant sites of failure
Timepoint [1] 206 0
3 years following commencement of treatment
Secondary outcome [1] 467 0
1. Determine the cumulative incidence of progression outside pre-transplant sites of failure
Timepoint [1] 467 0
3 years following commencement of treatment.
Secondary outcome [2] 468 0
2. Determine overall progression free survival and time to progression
Timepoint [2] 468 0
At 3 years.
Secondary outcome [3] 469 0
3. Assess selected toxicities attributable to protocol RT
Timepoint [3] 469 0
Secondary outcome [4] 470 0
Determine overall survival
Timepoint [4] 470 0
At 3 years.
Secondary outcome [5] 471 0
5. Document the time to haematological recovery from post-transplant RT-induced cytopaenia, which occurs after a progenitor cell infusion, and the duration of recovery.
Timepoint [5] 471 0
Secondary outcome [6] 472 0
6. Assess the prognostic significance of conventional and functional imaging response to cytoreduction chemotherapy.
Timepoint [6] 472 0

Eligibility
Key inclusion criteria
1. Histological diagnosis of HD or NHL other than follicular grade I-II, small lymphocytic and marginal zone lymphoma; 2. Failure to achieve CR with first line therapy, or relapse after CR to first line therapy*; 3. No more than 2 lines (ie regimens) of cytoreduction chemotherapy; 4. At least a 50% reduction in the sum of products of tumour diameters following cytoreduction chemotherapy (NHL only); 5. Sites of failure confined to lymph nodes, spleen, Waldeyer's ring and limited extra-nodal sites (solitary soft tissue deposit or single bone or one kidney or extension from nodal site into contiguous lung, pleura, pericardium, neural structure or liver) that can be treated within a tolerable RT field (histological evidence of bone marrow relapse is also permissible); 6. Sites of failure are adequately documented for RT planning; 7. The patient is planned to undergo autologous transplantation; 8. Confirmation of adequate progenitor cell harvest (> 2x106 CD34+ve cells/Kg); 9. The patient's age is at least 18; 10. The patient's ECOG performance status is two or less; 11. The patient has provided written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior dose-limiting RT to site requiring RT; 2. Planned TBI-based conditioning; 3. Sites of failure include haematogenous involvement of lung or liver parenchyma, brain or both kidneys; 4. Sites of failure include diffuse or disseminated involvement of pleura/pericardium, spinal cord/spinal meninges, bone or skin/soft tissue; 5. Any condition which in the opinion of the investigators puts patients at undue risk of RT toxicity; 6. Women who are pregnant or breast feeding 7. Patients who are not using adequate contraception (if relevant).

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
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2004
Actual
24/09/2003
Date of last participant enrolment
Anticipated
Actual
26/02/2009
Date of last data collection
Anticipated
Actual
15/08/2012
Sample size
Target
100
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 219 0
Other Collaborative groups
Name [1] 219 0
Royal Australian and New Zealand College of Radiologists
Country [1] 219 0
Australia
Funding source category [2] 220 0
Charities/Societies/Foundations
Name [2] 220 0
Peter MacCallum Cancer Centre Division of Radiation Oncology
Country [2] 220 0
Australia
Funding source category [3] 221 0
Commercial sector/Industry
Name [3] 221 0
Amgen Australia
Country [3] 221 0
Australia
Funding source category [4] 222 0
Commercial sector/Industry
Name [4] 222 0
Baxter Healthcare Australia
Country [4] 222 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
35 Elizabeth St, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 165 0
None
Name [1] 165 0
nil
Address [1] 165 0
NIL
Country [1] 165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1014 0
Royal Adelaide
Ethics committee address [1] 1014 0

Royal Adelaide Hospital
Level 3,
1 Port Rd
Adelaide, SA 5000
Ethics committee country [1] 1014 0
Australia
Date submitted for ethics approval [1] 1014 0
Approval date [1] 1014 0
28/03/2003
Ethics approval number [1] 1014 0
Ethics committee name [2] 1015 0
Alfred
Ethics committee address [2] 1015 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [2] 1015 0
Australia
Date submitted for ethics approval [2] 1015 0
Approval date [2] 1015 0
13/08/2003
Ethics approval number [2] 1015 0
Ethics committee name [3] 1016 0
Christchurch
Ethics committee address [3] 1016 0
Riccarton Avenue, Christchurch Central City, Christchurch 8011, New Zealand
Ethics committee country [3] 1016 0
New Zealand
Date submitted for ethics approval [3] 1016 0
Approval date [3] 1016 0
22/08/2003
Ethics approval number [3] 1016 0
Ethics committee name [4] 1017 0
Geelong
Ethics committee address [4] 1017 0
Bellerine St, Geelong VIC 3220
Ethics committee country [4] 1017 0
Australia
Date submitted for ethics approval [4] 1017 0
Approval date [4] 1017 0
01/03/2004
Ethics approval number [4] 1017 0
Ethics committee name [5] 1018 0
Mater Newcastle
Ethics committee address [5] 1018 0
Edith &, Platt St, Waratah NSW 2298
Ethics committee country [5] 1018 0
Australia
Date submitted for ethics approval [5] 1018 0
Approval date [5] 1018 0
17/05/2004
Ethics approval number [5] 1018 0
Ethics committee name [6] 1019 0
Peter MacCallum
Ethics committee address [6] 1019 0
305 Grattan St, Melbourne VIC 3000
Ethics committee country [6] 1019 0
Australia
Date submitted for ethics approval [6] 1019 0
Approval date [6] 1019 0
21/02/2003
Ethics approval number [6] 1019 0
Ethics committee name [7] 1020 0
Royal Prince Alfred
Ethics committee address [7] 1020 0
50 Missenden Rd, Camperdown NSW 2050
Ethics committee country [7] 1020 0
Australia
Date submitted for ethics approval [7] 1020 0
Approval date [7] 1020 0
07/05/2003
Ethics approval number [7] 1020 0
Ethics committee name [8] 1021 0
St Vincent's Melbourne
Ethics committee address [8] 1021 0
41 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [8] 1021 0
Australia
Date submitted for ethics approval [8] 1021 0
Approval date [8] 1021 0
12/05/2004
Ethics approval number [8] 1021 0
Ethics committee name [9] 1022 0
Westmead
Ethics committee address [9] 1022 0
nr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Ethics committee country [9] 1022 0
Australia
Date submitted for ethics approval [9] 1022 0
Approval date [9] 1022 0
01/05/2003
Ethics approval number [9] 1022 0

Summary
Brief summary
It has been found that if lymphoma recurs after transplantation it often does so in sites involved prior to transplantation. Radiotherapy can prevent some of these relapses, and may improve the overall results of transplantation. Radiotherapy is often given only to bulky sites (i.e more than 5-10 cm in size) of lymphoma following transplantation, but the optimal dose and area of radiotherapy is not known. It is possible that treating all the areas of lymphoma (including non-bulky areas) may be more effective.

In this research study, radiotherapy will be given to all the areas known to be affected by lymphoma (other than bone marrow). The aims of this study are to: (1) assess the ability of radiotherapy to reduce the risk of relapse following transplantation, and (2) carefully evaluate the side effects of adding radiotherapy to transplantation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35379 0
A/Prof Andrew Wirth
Address 35379 0
A/PROF ANDREW WIRTH
HAEMATOLOGICAL AND THORACIC CANCERS
Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Melbourne, VIC 8006
Country 35379 0
Australia
Phone 35379 0
+61 0385597777
Fax 35379 0
Email 35379 0
[email protected].
Contact person for public queries
Name 9305 0
A/Prof Dr Andrew Wirth
Address 9305 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 9305 0
Australia
Phone 9305 0
+61 3 96561111
Fax 9305 0
+61 3 96561424
Email 9305 0
email [email protected]
Contact person for scientific queries
Name 233 0
A/Prof Dr Andrew Wirth
Address 233 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 233 0
Australia
Phone 233 0
+61 3 96561111
Fax 233 0
+61 3 96561424
Email 233 0
email [email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19918Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):11... [More Details] 124-(Uploaded-03-09-2020-13-18-49)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.