A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer
Abstract Purpose To report results from our phase I dose-escalation study of stereotactic body radiotherapy (SBRT) using 4 fractions for patients with localized prostate cancer. Materials & methods Fraction sizes of 8 Gy, 8.5 Gy, and 9 Gy were defined as levels 1, 2, and 3. The prescribed dose w...
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| Format: | Article |
| Language: | English |
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BMC
2019-09-01
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| Series: | Radiation Oncology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13014-019-1369-y |
| _version_ | 1818339472298737664 |
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| author | Takuro Kainuma Shogo Kawakami Hideyasu Tsumura Takefumi Satoh Ken-ichi Tabata Masatsugu Iwamura Kazushige Hayakawa Hiromichi Ishiyama |
| author_facet | Takuro Kainuma Shogo Kawakami Hideyasu Tsumura Takefumi Satoh Ken-ichi Tabata Masatsugu Iwamura Kazushige Hayakawa Hiromichi Ishiyama |
| author_sort | Takuro Kainuma |
| collection | DOAJ |
| description | Abstract Purpose To report results from our phase I dose-escalation study of stereotactic body radiotherapy (SBRT) using 4 fractions for patients with localized prostate cancer. Materials & methods Fraction sizes of 8 Gy, 8.5 Gy, and 9 Gy were defined as levels 1, 2, and 3. The prescribed dose was delivered to at least 95% of the planning target volume. Image-guided, intensity-modulated radiotherapy was delivered to all patients. Dose-limiting toxicity (DLT) was defined as acute toxicity of Grade 3 or higher. The maximum tolerated dose (MTD) was defined as the level at which ≥30% of patients showed DLT. The recommended dose (RD) was defined to be one dose level below the MTD. If no patients at level 3 showed DLT, level 3 was defined as the recommended dose (RD). Results Nine patients were enrolled in each level. All patients were low or intermediate risk. Median durations of follow-up for patients at levels 1–3 were 48.9 months, 42.6 months, and 18.4 months, respectively. Protocol treatment was completed for all patients. No patient showed DLT at each dose level. Level 3 was therefore designated as the RD for the phase II study. Although most toxicities were Grade 1, genitourinary toxicity was common compared to gastrointestinal toxicity. Three-year biochemical control rate was 90.3%. Conclusion The dose level of 36 Gy in 4 fractions with a 2-day break was tolerable and highly encouraging for SBRT of localized prostate cancer. The phase II trial to confirm the efficacy and toxicity of this treatment is now on going. Trial registration UMIN, UMIN000010236. Registered 13 March 2013. |
| first_indexed | 2024-12-13T15:27:33Z |
| format | Article |
| id | doaj.art-d313a7c9708e43659e27cad460b54b3b |
| institution | Directory Open Access Journal |
| issn | 1748-717X |
| language | English |
| last_indexed | 2024-12-13T15:27:33Z |
| publishDate | 2019-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Radiation Oncology |
| spelling | doaj.art-d313a7c9708e43659e27cad460b54b3b2022-12-21T23:40:18ZengBMCRadiation Oncology1748-717X2019-09-011411610.1186/s13014-019-1369-yA phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancerTakuro Kainuma0Shogo Kawakami1Hideyasu Tsumura2Takefumi Satoh3Ken-ichi Tabata4Masatsugu Iwamura5Kazushige Hayakawa6Hiromichi Ishiyama7Department of Radiation Oncology, Kitasato University School of MedicineDepartment of Radiation Oncology, Kitasato University School of MedicineDepartment of Urology, Kitasato University School of MedicineDepartment of Urology, Kitasato University School of MedicineDepartment of Urology, Kitasato University School of MedicineDepartment of Urology, Kitasato University School of MedicineDepartment of Radiation Oncology, Kitasato University School of MedicineDepartment of Radiation Oncology, Kitasato University School of MedicineAbstract Purpose To report results from our phase I dose-escalation study of stereotactic body radiotherapy (SBRT) using 4 fractions for patients with localized prostate cancer. Materials & methods Fraction sizes of 8 Gy, 8.5 Gy, and 9 Gy were defined as levels 1, 2, and 3. The prescribed dose was delivered to at least 95% of the planning target volume. Image-guided, intensity-modulated radiotherapy was delivered to all patients. Dose-limiting toxicity (DLT) was defined as acute toxicity of Grade 3 or higher. The maximum tolerated dose (MTD) was defined as the level at which ≥30% of patients showed DLT. The recommended dose (RD) was defined to be one dose level below the MTD. If no patients at level 3 showed DLT, level 3 was defined as the recommended dose (RD). Results Nine patients were enrolled in each level. All patients were low or intermediate risk. Median durations of follow-up for patients at levels 1–3 were 48.9 months, 42.6 months, and 18.4 months, respectively. Protocol treatment was completed for all patients. No patient showed DLT at each dose level. Level 3 was therefore designated as the RD for the phase II study. Although most toxicities were Grade 1, genitourinary toxicity was common compared to gastrointestinal toxicity. Three-year biochemical control rate was 90.3%. Conclusion The dose level of 36 Gy in 4 fractions with a 2-day break was tolerable and highly encouraging for SBRT of localized prostate cancer. The phase II trial to confirm the efficacy and toxicity of this treatment is now on going. Trial registration UMIN, UMIN000010236. Registered 13 March 2013.http://link.springer.com/article/10.1186/s13014-019-1369-yProstate cancerStereotactic body radiotherapyDose-escalation |
| spellingShingle | Takuro Kainuma Shogo Kawakami Hideyasu Tsumura Takefumi Satoh Ken-ichi Tabata Masatsugu Iwamura Kazushige Hayakawa Hiromichi Ishiyama A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer Radiation Oncology Prostate cancer Stereotactic body radiotherapy Dose-escalation |
| title | A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer |
| title_full | A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer |
| title_fullStr | A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer |
| title_full_unstemmed | A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer |
| title_short | A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer |
| title_sort | phase i dose escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer |
| topic | Prostate cancer Stereotactic body radiotherapy Dose-escalation |
| url | http://link.springer.com/article/10.1186/s13014-019-1369-y |
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