Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): A multiarm Phase I trial
A multiarm Phase I clinical trial was performed to define the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) delivered by non-coplanar conformal beams or volumetric modulated arc therapy technique in seven predefined clinical settings. The (a) and (b) arms investigated primary...
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| Veröffentlicht in: | British journal of radiology 2019-02, Vol.92 (1094), p.20180422 |
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| creator | Deodato, Francesco Macchia, Gabriella Cilla, Savino Ianiro, Anna Sallustio, Giuseppina Cammelli, Silvia Buwenge, Milly Mattiucci, Gian Carlo Valentini, Vincenzo Morganti, Alessio G |
| description | A multiarm Phase I clinical trial was performed to define the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) delivered by non-coplanar conformal beams or volumetric modulated arc therapy technique in seven predefined clinical settings.
The (a) and (b) arms investigated primary and metastatic lung cancer differentiated by site of onset, arm (c) included primary or metastatic lesions outside the thorax, the (d) and (e) arms were for in-field reirradiation of recurrence, and finally, the (f) and (g) arms were for boost irradiation to the lesions after an adjuvant RT prescribed dose. A 4 months cut-off after previous irradiation course was fixed to distinguish the boost from the retreatment (4 months, respectively). Patients were prospectively enrolled in study arms according to tumor site, clinical stage and previous treatment. The total dose prescribed to the isocenter, ranged from 20 to 50 Gy according to the protocol design and the doses per fraction ranged from 4 to 10 Gy in 5 days.
A total of 281 patients (M/F: 167/114; median age: 69 years) with 376 lesions underwent SBRT. No acute toxicity was reported in 175 patients (62.3%) while 106 (37.7%) experienced only low-grade (G < 2) acute toxicity. Four patients (all previously irradiated in the same site) showed >Grade 2 toxicity within 6 months from SBRT. With a median follow-up of 19 months, 204 patients (72.6%) did not experience late toxicity, and 77 (27.4%) experienced low grade late toxicity. On per-lesion basis, the 12-and 24 months actuarial local control inside the SBRT field were 84.3 and 73.7 %, respectively.
SBRT delivered in five consecutive fractions up to the doses evaluated is well tolerated. The MTD was reached in four (a, b, c and f) of the seven study arms. Recruitment for (d), (e) and (g) arms is still ongoing.
In a prospective dose-escalation trial, the MTD of 50 Gy/10 Gy fraction and 35 Gy/7 Gy fraction were defined for primary and metastatic lesions and as boost after prior RT dose ≤50 Gy, respectively. |
| doi_str_mv | 10.1259/bjr.20180422 |
| format | Article |
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The (a) and (b) arms investigated primary and metastatic lung cancer differentiated by site of onset, arm (c) included primary or metastatic lesions outside the thorax, the (d) and (e) arms were for in-field reirradiation of recurrence, and finally, the (f) and (g) arms were for boost irradiation to the lesions after an adjuvant RT prescribed dose. A 4 months cut-off after previous irradiation course was fixed to distinguish the boost from the retreatment (<4 vs >4 months, respectively). Patients were prospectively enrolled in study arms according to tumor site, clinical stage and previous treatment. The total dose prescribed to the isocenter, ranged from 20 to 50 Gy according to the protocol design and the doses per fraction ranged from 4 to 10 Gy in 5 days.
A total of 281 patients (M/F: 167/114; median age: 69 years) with 376 lesions underwent SBRT. No acute toxicity was reported in 175 patients (62.3%) while 106 (37.7%) experienced only low-grade (G < 2) acute toxicity. Four patients (all previously irradiated in the same site) showed >Grade 2 toxicity within 6 months from SBRT. With a median follow-up of 19 months, 204 patients (72.6%) did not experience late toxicity, and 77 (27.4%) experienced low grade late toxicity. On per-lesion basis, the 12-and 24 months actuarial local control inside the SBRT field were 84.3 and 73.7 %, respectively.
SBRT delivered in five consecutive fractions up to the doses evaluated is well tolerated. The MTD was reached in four (a, b, c and f) of the seven study arms. Recruitment for (d), (e) and (g) arms is still ongoing.
In a prospective dose-escalation trial, the MTD of 50 Gy/10 Gy fraction and 35 Gy/7 Gy fraction were defined for primary and metastatic lesions and as boost after prior RT dose ≤50 Gy, respectively.</description><identifier>ISSN: 0007-1285</identifier><identifier>EISSN: 1748-880X</identifier><identifier>DOI: 10.1259/bjr.20180422</identifier><identifier>PMID: 30325662</identifier><language>eng</language><publisher>England: The British Institute of Radiology</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Dose Fractionation, Radiation ; Dose-Response Relationship, Radiation ; Female ; Humans ; Male ; Maximum Tolerated Dose ; Middle Aged ; Neoplasm Metastasis - radiotherapy ; Neoplasms - radiotherapy ; Prospective Studies ; Radiosurgery - adverse effects ; Radiotherapy Dosage ; Radiotherapy Planning, Computer-Assisted</subject><ispartof>British journal of radiology, 2019-02, Vol.92 (1094), p.20180422</ispartof><rights>2019 The Authors. Published by the British Institute of Radiology 2019 The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-ff9bb2f22dacd9076254374b47c6f1fcc2371992dc5b22bb833a430ed74cd4693</citedby><cites>FETCH-LOGICAL-c384t-ff9bb2f22dacd9076254374b47c6f1fcc2371992dc5b22bb833a430ed74cd4693</cites><orcidid>0000-0002-0529-201X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30325662$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Deodato, Francesco</creatorcontrib><creatorcontrib>Macchia, Gabriella</creatorcontrib><creatorcontrib>Cilla, Savino</creatorcontrib><creatorcontrib>Ianiro, Anna</creatorcontrib><creatorcontrib>Sallustio, Giuseppina</creatorcontrib><creatorcontrib>Cammelli, Silvia</creatorcontrib><creatorcontrib>Buwenge, Milly</creatorcontrib><creatorcontrib>Mattiucci, Gian Carlo</creatorcontrib><creatorcontrib>Valentini, Vincenzo</creatorcontrib><creatorcontrib>Morganti, Alessio G</creatorcontrib><title>Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): A multiarm Phase I trial</title><title>British journal of radiology</title><addtitle>Br J Radiol</addtitle><description>A multiarm Phase I clinical trial was performed to define the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) delivered by non-coplanar conformal beams or volumetric modulated arc therapy technique in seven predefined clinical settings.
The (a) and (b) arms investigated primary and metastatic lung cancer differentiated by site of onset, arm (c) included primary or metastatic lesions outside the thorax, the (d) and (e) arms were for in-field reirradiation of recurrence, and finally, the (f) and (g) arms were for boost irradiation to the lesions after an adjuvant RT prescribed dose. A 4 months cut-off after previous irradiation course was fixed to distinguish the boost from the retreatment (<4 vs >4 months, respectively). Patients were prospectively enrolled in study arms according to tumor site, clinical stage and previous treatment. The total dose prescribed to the isocenter, ranged from 20 to 50 Gy according to the protocol design and the doses per fraction ranged from 4 to 10 Gy in 5 days.
A total of 281 patients (M/F: 167/114; median age: 69 years) with 376 lesions underwent SBRT. No acute toxicity was reported in 175 patients (62.3%) while 106 (37.7%) experienced only low-grade (G < 2) acute toxicity. Four patients (all previously irradiated in the same site) showed >Grade 2 toxicity within 6 months from SBRT. With a median follow-up of 19 months, 204 patients (72.6%) did not experience late toxicity, and 77 (27.4%) experienced low grade late toxicity. On per-lesion basis, the 12-and 24 months actuarial local control inside the SBRT field were 84.3 and 73.7 %, respectively.
SBRT delivered in five consecutive fractions up to the doses evaluated is well tolerated. The MTD was reached in four (a, b, c and f) of the seven study arms. Recruitment for (d), (e) and (g) arms is still ongoing.
In a prospective dose-escalation trial, the MTD of 50 Gy/10 Gy fraction and 35 Gy/7 Gy fraction were defined for primary and metastatic lesions and as boost after prior RT dose ≤50 Gy, respectively.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Dose Fractionation, Radiation</subject><subject>Dose-Response Relationship, Radiation</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis - radiotherapy</subject><subject>Neoplasms - radiotherapy</subject><subject>Prospective Studies</subject><subject>Radiosurgery - adverse effects</subject><subject>Radiotherapy Dosage</subject><subject>Radiotherapy Planning, Computer-Assisted</subject><issn>0007-1285</issn><issn>1748-880X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkMtLAzEQh4MotlZvniVHBbfmtS8PQmmrFgoVraCnkGSzbso-SpIW-9-7pbboaRjmN98wHwCXGPUxCdM7ubB9gnCCGCFHoItjlgRJgj6OQRchFAeYJGEHnDm32LZhik5BhyJKwigiXVCMGqehdkqUwpumhqaG-ttboayojSih89rqxgvljYJCblNrDa3ITOMLbcVyA69H47f56-wzwDf3cACrVemNsBV8KUTLnkBvW9A5OMlF6fTFb-2B98fxfPgcTGdPk-FgGiiaMB_keSolyQnJhMpSFEckZDRmksUqynGuFKExTlOSqVASImVCqWAU6SxmKmNRSnvgYcddrmSlM6Xr9pmSL62phN3wRhj-f1Kbgn81ax4xxFpaC7jdAZRtnLM6P-xixLfGeWuc74238au_9w7hvWL6A1WRfhY</recordid><startdate>201902</startdate><enddate>201902</enddate><creator>Deodato, Francesco</creator><creator>Macchia, Gabriella</creator><creator>Cilla, Savino</creator><creator>Ianiro, Anna</creator><creator>Sallustio, Giuseppina</creator><creator>Cammelli, Silvia</creator><creator>Buwenge, Milly</creator><creator>Mattiucci, Gian Carlo</creator><creator>Valentini, Vincenzo</creator><creator>Morganti, Alessio G</creator><general>The British Institute of Radiology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-0529-201X</orcidid></search><sort><creationdate>201902</creationdate><title>Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): A multiarm Phase I trial</title><author>Deodato, Francesco ; Macchia, Gabriella ; Cilla, Savino ; Ianiro, Anna ; Sallustio, Giuseppina ; Cammelli, Silvia ; Buwenge, Milly ; Mattiucci, Gian Carlo ; Valentini, Vincenzo ; Morganti, Alessio G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-ff9bb2f22dacd9076254374b47c6f1fcc2371992dc5b22bb833a430ed74cd4693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Dose Fractionation, Radiation</topic><topic>Dose-Response Relationship, Radiation</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis - radiotherapy</topic><topic>Neoplasms - radiotherapy</topic><topic>Prospective Studies</topic><topic>Radiosurgery - adverse effects</topic><topic>Radiotherapy Dosage</topic><topic>Radiotherapy Planning, Computer-Assisted</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Deodato, Francesco</creatorcontrib><creatorcontrib>Macchia, Gabriella</creatorcontrib><creatorcontrib>Cilla, Savino</creatorcontrib><creatorcontrib>Ianiro, Anna</creatorcontrib><creatorcontrib>Sallustio, Giuseppina</creatorcontrib><creatorcontrib>Cammelli, Silvia</creatorcontrib><creatorcontrib>Buwenge, Milly</creatorcontrib><creatorcontrib>Mattiucci, Gian Carlo</creatorcontrib><creatorcontrib>Valentini, Vincenzo</creatorcontrib><creatorcontrib>Morganti, Alessio G</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of radiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Deodato, Francesco</au><au>Macchia, Gabriella</au><au>Cilla, Savino</au><au>Ianiro, Anna</au><au>Sallustio, Giuseppina</au><au>Cammelli, Silvia</au><au>Buwenge, Milly</au><au>Mattiucci, Gian Carlo</au><au>Valentini, Vincenzo</au><au>Morganti, Alessio G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): A multiarm Phase I trial</atitle><jtitle>British journal of radiology</jtitle><addtitle>Br J Radiol</addtitle><date>2019-02</date><risdate>2019</risdate><volume>92</volume><issue>1094</issue><spage>20180422</spage><pages>20180422-</pages><issn>0007-1285</issn><eissn>1748-880X</eissn><abstract>A multiarm Phase I clinical trial was performed to define the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) delivered by non-coplanar conformal beams or volumetric modulated arc therapy technique in seven predefined clinical settings.
The (a) and (b) arms investigated primary and metastatic lung cancer differentiated by site of onset, arm (c) included primary or metastatic lesions outside the thorax, the (d) and (e) arms were for in-field reirradiation of recurrence, and finally, the (f) and (g) arms were for boost irradiation to the lesions after an adjuvant RT prescribed dose. A 4 months cut-off after previous irradiation course was fixed to distinguish the boost from the retreatment (<4 vs >4 months, respectively). Patients were prospectively enrolled in study arms according to tumor site, clinical stage and previous treatment. The total dose prescribed to the isocenter, ranged from 20 to 50 Gy according to the protocol design and the doses per fraction ranged from 4 to 10 Gy in 5 days.
A total of 281 patients (M/F: 167/114; median age: 69 years) with 376 lesions underwent SBRT. No acute toxicity was reported in 175 patients (62.3%) while 106 (37.7%) experienced only low-grade (G < 2) acute toxicity. Four patients (all previously irradiated in the same site) showed >Grade 2 toxicity within 6 months from SBRT. With a median follow-up of 19 months, 204 patients (72.6%) did not experience late toxicity, and 77 (27.4%) experienced low grade late toxicity. On per-lesion basis, the 12-and 24 months actuarial local control inside the SBRT field were 84.3 and 73.7 %, respectively.
SBRT delivered in five consecutive fractions up to the doses evaluated is well tolerated. The MTD was reached in four (a, b, c and f) of the seven study arms. Recruitment for (d), (e) and (g) arms is still ongoing.
In a prospective dose-escalation trial, the MTD of 50 Gy/10 Gy fraction and 35 Gy/7 Gy fraction were defined for primary and metastatic lesions and as boost after prior RT dose ≤50 Gy, respectively.</abstract><cop>England</cop><pub>The British Institute of Radiology</pub><pmid>30325662</pmid><doi>10.1259/bjr.20180422</doi><orcidid>https://orcid.org/0000-0002-0529-201X</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals |
| subjects | Adult Aged Aged, 80 and over Dose Fractionation, Radiation Dose-Response Relationship, Radiation Female Humans Male Maximum Tolerated Dose Middle Aged Neoplasm Metastasis - radiotherapy Neoplasms - radiotherapy Prospective Studies Radiosurgery - adverse effects Radiotherapy Dosage Radiotherapy Planning, Computer-Assisted |
| title | Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): A multiarm Phase I trial |
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