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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000073606

Enrollment

Registered

2005-08-04

Start date

2003-09-24

Completion date

2009-02-26

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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).

Outcome results