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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000124
ACTR Number: ACTRN12605000073606
Trial Status: Registered
Date Submitted: 4/08/2005
Date Registered: 4/08/2005

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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
ANZCTR registration 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:Australasian Leukaemia and Lymphoma Group (ALLG): ALLG HDNHL4 
UTN:
Trial acronym:

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

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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:Treatment: Other 
Comparator / control treatment:
Control group: Uncontrolled

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Primary outcome:Determine the cumulative incidence of progression in irradiated pre-transplant sites of failure 
Timepoint:3 years following commencement of treatment 
Secondary outcome 1:1. Determine the cumulative incidence of progression outside pre-transplant sites of failure 
Timepoint:3 years following commencement of treatment. 
Secondary outcome 2:2. Determine overall progression free survival and time to progression 
Timepoint:At 3 years. 
Secondary outcome 3:3. Assess selected toxicities attributable to protocol RT 
Timepoint: 
Secondary outcome 4:Determine overall survival 
Timepoint:At 3 years. 
Secondary outcome 5:5. 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: 
Secondary outcome 6:6. Assess the prognostic significance of conventional and functional imaging response to cytoreduction chemotherapy. 
Timepoint: 

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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
Gender: Both males and females
Healthy volunteers? 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).

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Single group
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 2
Anticipated or actual date of first participant enrolement: 9/01/2004
Target sample size: 100
Recruitment status: Open to recruitment

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Funding source 1:Other Collaborative groups 
Name:Royal Australian and New Zealand College of Radiologists 
Address: 
Country:Australia 
Funding source 2:Charities/Societies/Foundations 
Name:Peter MacCallum Cancer Centre Division of Radiation Oncology 
Address: 
Country:Australia 
Funding source 3:Commercial sector/Industry 
Name:Amgen Australia 
Address: 
Country:Australia 
Funding source 4:Commercial sector/Industry 
Name:Baxter Healthcare Australia 
Address: 
Country:Australia 
Primary sponsor: Other Collaborative groups
Name: Australasian Leukaemia and Lymphoma Group
Address:
Country: Australia
Secondary sponsor:None 
Name:nil 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Royal Adelaide 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Alfred 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 3:Christchurch 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 4:Geelong 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 5:Mater Newcastle 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 6:Peter MacCallum 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 7:Royal Prince Alfred 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 8:St Vincent's Melbourne 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 9:Westmead 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dr Andrew Wirth
Address: Peter MacCallum Cancer Centre St Andrews Place East Melbourne VIC 3002
Country: Australia
Tel: +61 3 96561111
Fax: +61 3 96561424
Email: email andrew.wirth@petermac.org

Contact person for scientific queries
Name: Dr Andrew Wirth
Address: Peter MacCallum Cancer Centre St Andrews Place East Melbourne VIC 3002
Country: Australia
Tel: +61 3 96561111
Fax: +61 3 96561424
Email: email andrew.wirth@petermac.org

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