Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702)
Abstract Purpose To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc. Materials and methods The continual reassessment method...
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| Veröffentlicht in: | Radiotherapy and oncology 2015-08, Vol.116 (2), p.276-280 |
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| creator | Onimaru, Rikiya Shirato, Hiroki Shibata, Taro Hiraoka, Masahiro Ishikura, Satoshi Karasawa, Katsuyuki Matsuo, Yukinori Kokubo, Masaki Shioyama, Yoshiyuki Matsushita, Haruo Ito, Yoshinori Onishi, Hiroshi |
| description | Abstract Purpose To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc. Materials and methods The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV. Results Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions. Conclusions The RD of SBRT for peripheral T2N0M0 NSCLC with PTV < 100 cc was determined to be 55 Gy in 4 fractions. |
| doi_str_mv | 10.1016/j.radonc.2015.07.008 |
| format | Article |
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Materials and methods The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV. Results Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions. Conclusions The RD of SBRT for peripheral T2N0M0 NSCLC with PTV < 100 cc was determined to be 55 Gy in 4 fractions.</description><identifier>ISSN: 0167-8140</identifier><identifier>EISSN: 1879-0887</identifier><identifier>DOI: 10.1016/j.radonc.2015.07.008</identifier><identifier>PMID: 26233591</identifier><language>eng</language><publisher>Ireland</publisher><subject>Aged ; Aged, 80 and over ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Non-Small-Cell Lung - surgery ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Lung Neoplasms - pathology ; Lung Neoplasms - surgery ; Male ; Maximum Tolerated Dose ; Neoplasm Staging ; Radiosurgery - adverse effects ; Radiotherapy Dosage</subject><ispartof>Radiotherapy and oncology, 2015-08, Vol.116 (2), p.276-280</ispartof><rights>Elsevier Ireland Ltd</rights><rights>Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c452t-f1be980bb2151a7a8c7e7474207323bc7f4555c20a21afc5ee6c0de913b7da5e3</citedby><cites>FETCH-LOGICAL-c452t-f1be980bb2151a7a8c7e7474207323bc7f4555c20a21afc5ee6c0de913b7da5e3</cites><orcidid>0000-0002-8615-2165 ; 0000-0002-4372-8259 ; 0000-0002-4768-2358</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26233591$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Onimaru, Rikiya</creatorcontrib><creatorcontrib>Shirato, Hiroki</creatorcontrib><creatorcontrib>Shibata, Taro</creatorcontrib><creatorcontrib>Hiraoka, Masahiro</creatorcontrib><creatorcontrib>Ishikura, Satoshi</creatorcontrib><creatorcontrib>Karasawa, Katsuyuki</creatorcontrib><creatorcontrib>Matsuo, Yukinori</creatorcontrib><creatorcontrib>Kokubo, Masaki</creatorcontrib><creatorcontrib>Shioyama, Yoshiyuki</creatorcontrib><creatorcontrib>Matsushita, Haruo</creatorcontrib><creatorcontrib>Ito, Yoshinori</creatorcontrib><creatorcontrib>Onishi, Hiroshi</creatorcontrib><title>Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702)</title><title>Radiotherapy and oncology</title><addtitle>Radiother Oncol</addtitle><description>Abstract Purpose To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc. Materials and methods The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV. Results Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions. Conclusions The RD of SBRT for peripheral T2N0M0 NSCLC with PTV < 100 cc was determined to be 55 Gy in 4 fractions.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Non-Small-Cell Lung - surgery</subject><subject>Female</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Lung Neoplasms - pathology</subject><subject>Lung Neoplasms - surgery</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Neoplasm Staging</subject><subject>Radiosurgery - adverse effects</subject><subject>Radiotherapy Dosage</subject><issn>0167-8140</issn><issn>1879-0887</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kVGP1CAQgBuj8fZO_4ExPJ4PrQMtpU2Midnoeeb0LnH1lVA6dVlbqEC97D_yZ0qzpy_AwDczGb4se0GhoEDr14fCq95ZXTCgvABRADSPsg1tRJtD04jH2SZhIm9oBWfZeQgHAGBQiqfZGatZWfKWbrI_d3sVkFyTEJf-SNyQDujRRaWj0aRz6TL1MSoaZ0nco1fzkQzOkxm9mdd4JDv2BT4Dsc7mYVLjSDSmZVzsD6KV1ejJvYl7crf7Tt4QCkC0Jksw6VkR7Ww0dklVPKoQMIQJbSQTxr3ryeWn7e0VCGCvnmVPBjUGfP6wX2TfPrzfbT_mN7dX19t3N7muOIv5QDtsG-g6RjlVQjVaoKhExUCUrOy0GCrOuWagGFWD5oi1hh5bWnaiVxzLi-zyVHf27teCIcrJhHUeZdEtQVJB24qxkrYJrU6o9i4Ej4OcvZmUP0oKcnUkD_LkSK6OJAiZHKW0lw8dlm7C_n_SPykJeHsCMM3526CXejTWaDX-xCOGg1u8TV8gqQxMgvy6al4tUw5Q1lCXfwEWfKPa</recordid><startdate>20150801</startdate><enddate>20150801</enddate><creator>Onimaru, Rikiya</creator><creator>Shirato, Hiroki</creator><creator>Shibata, Taro</creator><creator>Hiraoka, Masahiro</creator><creator>Ishikura, Satoshi</creator><creator>Karasawa, Katsuyuki</creator><creator>Matsuo, Yukinori</creator><creator>Kokubo, Masaki</creator><creator>Shioyama, Yoshiyuki</creator><creator>Matsushita, Haruo</creator><creator>Ito, Yoshinori</creator><creator>Onishi, Hiroshi</creator><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>7X8</scope><orcidid>https://orcid.org/0000-0002-8615-2165</orcidid><orcidid>https://orcid.org/0000-0002-4372-8259</orcidid><orcidid>https://orcid.org/0000-0002-4768-2358</orcidid></search><sort><creationdate>20150801</creationdate><title>Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702)</title><author>Onimaru, Rikiya ; Shirato, Hiroki ; Shibata, Taro ; Hiraoka, Masahiro ; Ishikura, Satoshi ; Karasawa, Katsuyuki ; Matsuo, Yukinori ; Kokubo, Masaki ; Shioyama, Yoshiyuki ; Matsushita, Haruo ; Ito, Yoshinori ; Onishi, Hiroshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c452t-f1be980bb2151a7a8c7e7474207323bc7f4555c20a21afc5ee6c0de913b7da5e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Carcinoma, Non-Small-Cell Lung - surgery</topic><topic>Female</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Lung Neoplasms - pathology</topic><topic>Lung Neoplasms - surgery</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Neoplasm Staging</topic><topic>Radiosurgery - adverse effects</topic><topic>Radiotherapy Dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Onimaru, Rikiya</creatorcontrib><creatorcontrib>Shirato, Hiroki</creatorcontrib><creatorcontrib>Shibata, Taro</creatorcontrib><creatorcontrib>Hiraoka, Masahiro</creatorcontrib><creatorcontrib>Ishikura, Satoshi</creatorcontrib><creatorcontrib>Karasawa, Katsuyuki</creatorcontrib><creatorcontrib>Matsuo, Yukinori</creatorcontrib><creatorcontrib>Kokubo, Masaki</creatorcontrib><creatorcontrib>Shioyama, Yoshiyuki</creatorcontrib><creatorcontrib>Matsushita, Haruo</creatorcontrib><creatorcontrib>Ito, Yoshinori</creatorcontrib><creatorcontrib>Onishi, Hiroshi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Radiotherapy and oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Onimaru, Rikiya</au><au>Shirato, Hiroki</au><au>Shibata, Taro</au><au>Hiraoka, Masahiro</au><au>Ishikura, Satoshi</au><au>Karasawa, Katsuyuki</au><au>Matsuo, Yukinori</au><au>Kokubo, Masaki</au><au>Shioyama, Yoshiyuki</au><au>Matsushita, Haruo</au><au>Ito, Yoshinori</au><au>Onishi, Hiroshi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702)</atitle><jtitle>Radiotherapy and oncology</jtitle><addtitle>Radiother Oncol</addtitle><date>2015-08-01</date><risdate>2015</risdate><volume>116</volume><issue>2</issue><spage>276</spage><epage>280</epage><pages>276-280</pages><issn>0167-8140</issn><eissn>1879-0887</eissn><abstract>Abstract Purpose To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc. Materials and methods The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV. Results Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions. Conclusions The RD of SBRT for peripheral T2N0M0 NSCLC with PTV < 100 cc was determined to be 55 Gy in 4 fractions.</abstract><cop>Ireland</cop><pmid>26233591</pmid><doi>10.1016/j.radonc.2015.07.008</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-8615-2165</orcidid><orcidid>https://orcid.org/0000-0002-4372-8259</orcidid><orcidid>https://orcid.org/0000-0002-4768-2358</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0167-8140 |
| ispartof | Radiotherapy and oncology, 2015-08, Vol.116 (2), p.276-280 |
| issn | 0167-8140 1879-0887 |
| language | eng |
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| subjects | Aged Aged, 80 and over Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Non-Small-Cell Lung - surgery Female Hematology, Oncology and Palliative Medicine Humans Lung Neoplasms - pathology Lung Neoplasms - surgery Male Maximum Tolerated Dose Neoplasm Staging Radiosurgery - adverse effects Radiotherapy Dosage |
| title | Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702) |
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