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Clinical Trial
. 2014 May 13;110(10):2389-95.
doi: 10.1038/bjc.2014.191. Epub 2014 Apr 10.

Phase I/II trial of definitive carbon ion radiotherapy for prostate cancer: evaluation of shortening of treatment period to 3 weeks

T Nomiya  1 , H Tsuji  1 , K Maruyama  1 , S Toyama  1 , H Suzuki  2 , K Akakura  3 , J Shimazaki  4 , K Nemoto  5 , T Kamada  1 , H Tsujii  1 ; Working Group for Genitourinary Tumors
Affiliations
Clinical Trial

Phase I/II trial of definitive carbon ion radiotherapy for prostate cancer: evaluation of shortening of treatment period to 3 weeks

T Nomiya et al. Br J Cancer. .

Abstract

Background: The purpose of this study was to evaluate the feasibility of a new shortened 3-week treatment schedule of carbon ion radiotherapy (CIRT) for prostate cancer.

Methods: Beginning in May 2010, patients with T1b-T3bN0M0, histologically proven prostate adenocarcinoma were enrolled in the phase II trial of CIRT. Patients received 51.6 GyE in 12 fractions over 3 weeks (protocol 1002). The primary end point was defined as the incidence of late adverse events that were evaluated based on the Common Terminology Criteria for Adverse Events version 4.0. Biochemical failure was determined using the Phoenix definition (nadir +2.0 ng ml(-1)).

Results: Forty-six patients were enrolled, and all patients were included in the analysis. The number of low-, intermediate-, and high-risk patients was 12 (26%), 9 (20%), and 25 (54%), respectively. The median follow-up period of surviving patients was 32.3 months. Two patients had intercurrent death without recurrence, and the remaining 44 patients were alive at the time of this analysis. In the analysis of late toxicities, grade 1 (G1) rectal haemorrhage was observed in 3 (7%) patients. The incidence of G1 haematuria was observed in 6 (13%) patients, and G1 urinary frequency was observed in 17 (37%) patients. No ⩾G2 late toxicities were observed. In the analysis of acute toxicities, 2 (4%) patients showed G2 urinary frequency, and no other G2 acute toxicities were observed.

Conclusions: The new shortened CIRT schedule over 3 weeks was considered as feasible. The analysis of long-term outcome is warranted.

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Figures

Figure 1
Figure 1
Chart of the trial. The patients who did not meet the inclusion criteria of 9904(3) (CIRT over 4 weeks) and who wished to participate were enrolled in the study (1002).
See this image and copyright information in PMC

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