Phase III randomised trialReduced dose radiotherapy for local control in non-Hodgkin lymphoma: A randomised phase III trial☆,☆☆
Section snippets
Study design
This prospective, randomised study was initiated and supported by the BNLI and subsequently the National Cancer Research Institute (NCRI) Lymphoma and Radiotherapy Clinical Studies Groups. Appropriate ethical approval was obtained, in accordance with the Declaration of Helsinki. Trial execution was overseen by an independent data monitoring committee. The data analysis, preparation of the manuscript, and interpretation were performed independently from the funders.
Eligibility
Consenting patients aged 18
Results
Between April 1997 and January 2005, 1001(361 indolent, 640 aggressive) randomised treatment allocations were made from 40 treatment centres (998 patients; 3 had 2 separate randomisations) as shown in Consort diagram (Fig. 1). The baseline characteristics were well balanced between arms (Table 1). 83% of patients were to receive radiotherapy as, or as part of, first-line therapy, with the remainder being for relapsed or resistant disease. Of note, the patient population had predominantly
Discussion
This large, randomised trial found no difference in local control of NHL comparing low-dose (24 Gy in indolent NHL; 30 Gy aggressive NHL) with conventional dose (40–45 Gy) radiotherapy. Furthermore, there was no significant difference detected in the in-field progression-free interval, PFS or OS in the low and high dose levels. Importantly the rates of local control were excellent for all radiotherapy doses, with ORR of 93% for indolent lymphoma and 91% for aggressive disease. This is higher than
Acknowledgements
We thank all patients who participated in this trial and research staff at the clinical centres who helped to recruit patients and collect data. We thank the staff of the Haematology Trials Group, CR UK & UCL Cancer Trials Centre, formerly the British National Lymphoma Investigation, for trial and data management. Thanks also to the staff at HMDS for their work obtaining central histological review.
Trial Management Group (TMG): Peter Hoskin (Chief Investigator), David Linch, Paul Smith, Wendi
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This was a British National Lymphoma Investigation randomised trial, ISRCTN71826974 and was funded by the Lymphoma Research Trust.
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Preliminary results previously reported orally at the 9th International Conference on Malignant Lymphoma (Annals of Oncology 2005; 16 supp 5:abstract 59).