Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508)
To evaluate the efficacy and the toxicity of prophylactic extended-field carbon-ion radiotherapy (C-ion RT, Protocol 0508) for locally advanced squamous cell carcinoma of the uterine cervix in phase I / II clinical trial. Between May 2006 and January 2012, 26 patients of Protocol 0508 were treated w...
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| Veröffentlicht in: | PloS one 2015-05, Vol.10 (5), p.e0127587-e0127587 |
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| creator | Wakatsuki, Masaru Kato, Shingo Kiyohara, Hiroki Ohno, Tatsuya Karasawa, Kumiko Tamaki, Tomoaki Ando, Ken Tsujii, Hirohiko Nakano, Takashi Kamada, Tadashi Shozu, Makio |
| description | To evaluate the efficacy and the toxicity of prophylactic extended-field carbon-ion radiotherapy (C-ion RT, Protocol 0508) for locally advanced squamous cell carcinoma of the uterine cervix in phase I / II clinical trial. Between May 2006 and January 2012, 26 patients of Protocol 0508 were treated with C-ion RT. The numbers of patients with stage IIB, IIIB, and IVA disease were 13, 11, and 2, respectively. Twenty patients had pelvic lymph node metastases. Median tumor size was 6.1 cm (range, 4.0–10.0 cm). The treatment consisted of extended-field irradiation of 39.0 gray equivalents (GyE) in 13 fractions, and additional 15.0 GyE in 5 fractions was given to the gross tumor volume (GTV) and surrounding tissues. With regard to local boost, 18.0 GyE in 2 fractions was given to GTV only. Total dose to the cervical tumor was 72.0 GyE over 20 fractions. The median follow-up period was 37 months. Twenty-one patients had grade 1 or 2 acute gastrointestinal toxicity, but all patients completed the treatment on schedule. There were no grade 3 or higher late complications, with 8 patients having grade 1 or 2 toxicities, 1 had grade 2 gastrointestinal toxicity and 2 had grade 2 genitourinary toxicity. Four patients (15.4%) developed local recurrence, and 8 patients (30.8%) had distant metastases. The 2-year local control rate, progression-free survival rate and overall survival rate were 83.6%, 61.5% and 73.1%, respectively. There were no severe acute or late complications in this trial. Prophylactic extended-field C-ion RT for locally advanced squamous cell carcinoma of the uterine cervix was a safe treatment. Although the number of patients in this study was small, the results support further investigations to confirm the therapeutic efficacy and to avoid or reduce toxicity.
UMIN-CTR UMIN000016169. |
| doi_str_mv | 10.1371/journal.pone.0127587 |
| format | Article |
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This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Wakatsuki et al 2015 Wakatsuki et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c758t-4d71c4773e9b5756ff9b84cb367cfedffe8097d758581f9d2cb38b2abf6fd0263</citedby><cites>FETCH-LOGICAL-c758t-4d71c4773e9b5756ff9b84cb367cfedffe8097d758581f9d2cb38b2abf6fd0263</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4439043/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4439043/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25993047$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Deutsch, Eric</contributor><creatorcontrib>Wakatsuki, Masaru</creatorcontrib><creatorcontrib>Kato, Shingo</creatorcontrib><creatorcontrib>Kiyohara, Hiroki</creatorcontrib><creatorcontrib>Ohno, Tatsuya</creatorcontrib><creatorcontrib>Karasawa, Kumiko</creatorcontrib><creatorcontrib>Tamaki, Tomoaki</creatorcontrib><creatorcontrib>Ando, Ken</creatorcontrib><creatorcontrib>Tsujii, Hirohiko</creatorcontrib><creatorcontrib>Nakano, Takashi</creatorcontrib><creatorcontrib>Kamada, Tadashi</creatorcontrib><creatorcontrib>Shozu, Makio</creatorcontrib><creatorcontrib>Working Group of the Gynecological Tumor</creatorcontrib><creatorcontrib>The Working Group of the Gynecological Tumor</creatorcontrib><title>Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508)</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>To evaluate the efficacy and the toxicity of prophylactic extended-field carbon-ion radiotherapy (C-ion RT, Protocol 0508) for locally advanced squamous cell carcinoma of the uterine cervix in phase I / II clinical trial. Between May 2006 and January 2012, 26 patients of Protocol 0508 were treated with C-ion RT. The numbers of patients with stage IIB, IIIB, and IVA disease were 13, 11, and 2, respectively. Twenty patients had pelvic lymph node metastases. Median tumor size was 6.1 cm (range, 4.0–10.0 cm). The treatment consisted of extended-field irradiation of 39.0 gray equivalents (GyE) in 13 fractions, and additional 15.0 GyE in 5 fractions was given to the gross tumor volume (GTV) and surrounding tissues. With regard to local boost, 18.0 GyE in 2 fractions was given to GTV only. Total dose to the cervical tumor was 72.0 GyE over 20 fractions. The median follow-up period was 37 months. Twenty-one patients had grade 1 or 2 acute gastrointestinal toxicity, but all patients completed the treatment on schedule. There were no grade 3 or higher late complications, with 8 patients having grade 1 or 2 toxicities, 1 had grade 2 gastrointestinal toxicity and 2 had grade 2 genitourinary toxicity. Four patients (15.4%) developed local recurrence, and 8 patients (30.8%) had distant metastases. The 2-year local control rate, progression-free survival rate and overall survival rate were 83.6%, 61.5% and 73.1%, respectively. There were no severe acute or late complications in this trial. Prophylactic extended-field C-ion RT for locally advanced squamous cell carcinoma of the uterine cervix was a safe treatment. Although the number of patients in this study was small, the results support further investigations to confirm the therapeutic efficacy and to avoid or reduce toxicity.
UMIN-CTR UMIN000016169.</description><subject>Adult</subject><subject>Aged</subject><subject>Biology</subject><subject>Cancer therapies</subject><subject>Carbon</subject><subject>Cervical cancer</subject><subject>Chemotherapy</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Complications</subject><subject>Diagnosis</subject><subject>Disease-Free Survival</subject><subject>Dose-Response Relationship, Radiation</subject><subject>Drug dosages</subject><subject>Female</subject><subject>Gynecology</subject><subject>Heavy Ion Radiotherapy - adverse effects</subject><subject>Humans</subject><subject>Ion beams</subject><subject>Irradiation</subject><subject>Lymph nodes</subject><subject>Lymphatic system</subject><subject>Medicine</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Oncology</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Physics</subject><subject>Proton beam radiotherapy</subject><subject>Quality</subject><subject>Radiation</subject><subject>Radiation therapy</subject><subject>Risk factors</subject><subject>Squamous cell carcinoma</subject><subject>Studies</subject><subject>Survival</subject><subject>Tissues</subject><subject>Tomography</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>University graduates</subject><subject>Uterine cancer</subject><subject>Uterine Cervical Neoplasms - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wakatsuki, Masaru</au><au>Kato, Shingo</au><au>Kiyohara, Hiroki</au><au>Ohno, Tatsuya</au><au>Karasawa, Kumiko</au><au>Tamaki, Tomoaki</au><au>Ando, Ken</au><au>Tsujii, Hirohiko</au><au>Nakano, Takashi</au><au>Kamada, Tadashi</au><au>Shozu, Makio</au><au>Deutsch, Eric</au><aucorp>Working Group of the Gynecological Tumor</aucorp><aucorp>The Working Group of the Gynecological Tumor</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2015-05-20</date><risdate>2015</risdate><volume>10</volume><issue>5</issue><spage>e0127587</spage><epage>e0127587</epage><pages>e0127587-e0127587</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>To evaluate the efficacy and the toxicity of prophylactic extended-field carbon-ion radiotherapy (C-ion RT, Protocol 0508) for locally advanced squamous cell carcinoma of the uterine cervix in phase I / II clinical trial. Between May 2006 and January 2012, 26 patients of Protocol 0508 were treated with C-ion RT. The numbers of patients with stage IIB, IIIB, and IVA disease were 13, 11, and 2, respectively. Twenty patients had pelvic lymph node metastases. Median tumor size was 6.1 cm (range, 4.0–10.0 cm). The treatment consisted of extended-field irradiation of 39.0 gray equivalents (GyE) in 13 fractions, and additional 15.0 GyE in 5 fractions was given to the gross tumor volume (GTV) and surrounding tissues. With regard to local boost, 18.0 GyE in 2 fractions was given to GTV only. Total dose to the cervical tumor was 72.0 GyE over 20 fractions. The median follow-up period was 37 months. Twenty-one patients had grade 1 or 2 acute gastrointestinal toxicity, but all patients completed the treatment on schedule. There were no grade 3 or higher late complications, with 8 patients having grade 1 or 2 toxicities, 1 had grade 2 gastrointestinal toxicity and 2 had grade 2 genitourinary toxicity. Four patients (15.4%) developed local recurrence, and 8 patients (30.8%) had distant metastases. The 2-year local control rate, progression-free survival rate and overall survival rate were 83.6%, 61.5% and 73.1%, respectively. There were no severe acute or late complications in this trial. Prophylactic extended-field C-ion RT for locally advanced squamous cell carcinoma of the uterine cervix was a safe treatment. Although the number of patients in this study was small, the results support further investigations to confirm the therapeutic efficacy and to avoid or reduce toxicity.
UMIN-CTR UMIN000016169.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>25993047</pmid><doi>10.1371/journal.pone.0127587</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2015-05, Vol.10 (5), p.e0127587-e0127587 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1682209820 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Aged Biology Cancer therapies Carbon Cervical cancer Chemotherapy Clinical outcomes Clinical trials Complications Diagnosis Disease-Free Survival Dose-Response Relationship, Radiation Drug dosages Female Gynecology Heavy Ion Radiotherapy - adverse effects Humans Ion beams Irradiation Lymph nodes Lymphatic system Medicine Metastases Metastasis Middle Aged Neoplasm Staging NMR Nuclear magnetic resonance Oncology Patient outcomes Patients Physics Proton beam radiotherapy Quality Radiation Radiation therapy Risk factors Squamous cell carcinoma Studies Survival Tissues Tomography Toxicity Treatment Outcome Tumors University graduates Uterine cancer Uterine Cervical Neoplasms - pathology Uterine Cervical Neoplasms - radiotherapy Uterus Working groups |
| title | Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508) |
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