Prospective Multi-Institutional Study of Definitive Radiotherapy With High-Dose-Rate Intracavitary Brachytherapy in Patients With Nonbulky (<4-cm) Stage I and II Uterine Cervical Cancer (JAROG0401/JROSG04-2)

Purpose To determine the efficacy of a definitive radiotherapy protocol using high-dose-rate intracavitary brachytherapy (HDR-ICBT) with a low cumulative dose schedule in nonbulky early-stage cervical cancer patients, we conducted a prospective multi-institutional study. Methods and Materials Eligib...

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Veröffentlicht in:International journal of radiation oncology, biology, physics biology, physics, 2012, Vol.82 (1), p.e49-e56
Hauptverfasser: Toita, Takafumi, M.D., Ph.D, Kato, Shingo, M.D., Ph.D, Niibe, Yuzuru, M.D., Ph.D, Ohno, Tatsuya, M.D., Ph.D, Kazumoto, Tomoko, M.D., Ph.D, Kodaira, Takeshi, M.D., Ph.D, Kataoka, Masaaki, M.D., Ph.D, Shikama, Naoto, M.D., Ph.D, Kenjo, Masahiro, M.D., Ph.D, Tokumaru, Sunao, M.D, Yamauchi, Chikako, M.D., Ph.D, Suzuki, Osamu, M.D., Ph.D, Sakurai, Hideyuki, M.D., Ph.D, Numasaki, Hodaka, Ph.D, Teshima, Teruki, M.D., Ph.D, Oguchi, Masahiko, M.D., Ph.D, Kagami, Yoshikazu, M.D., Ph.D, Nakano, Takashi, M.D., Ph.D, Hiraoka, Masahiro, M.D., Ph.D, Mitsuhashi, Norio, M.D., Ph.D
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container_issue 1
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container_title International journal of radiation oncology, biology, physics
container_volume 82
creator Toita, Takafumi, M.D., Ph.D
Kato, Shingo, M.D., Ph.D
Niibe, Yuzuru, M.D., Ph.D
Ohno, Tatsuya, M.D., Ph.D
Kazumoto, Tomoko, M.D., Ph.D
Kodaira, Takeshi, M.D., Ph.D
Kataoka, Masaaki, M.D., Ph.D
Shikama, Naoto, M.D., Ph.D
Kenjo, Masahiro, M.D., Ph.D
Tokumaru, Sunao, M.D
Yamauchi, Chikako, M.D., Ph.D
Suzuki, Osamu, M.D., Ph.D
Sakurai, Hideyuki, M.D., Ph.D
Numasaki, Hodaka, Ph.D
Teshima, Teruki, M.D., Ph.D
Oguchi, Masahiko, M.D., Ph.D
Kagami, Yoshikazu, M.D., Ph.D
Nakano, Takashi, M.D., Ph.D
Hiraoka, Masahiro, M.D., Ph.D
Mitsuhashi, Norio, M.D., Ph.D
description Purpose To determine the efficacy of a definitive radiotherapy protocol using high-dose-rate intracavitary brachytherapy (HDR-ICBT) with a low cumulative dose schedule in nonbulky early-stage cervical cancer patients, we conducted a prospective multi-institutional study. Methods and Materials Eligible patients had squamous cell carcinoma of the intact uterine cervix, Federation of Gynecologic Oncology and Obstetrics (FIGO) stages Ib1, IIa, and IIb, tumor size
doi_str_mv 10.1016/j.ijrobp.2011.01.022
format Article
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Methods and Materials Eligible patients had squamous cell carcinoma of the intact uterine cervix, Federation of Gynecologic Oncology and Obstetrics (FIGO) stages Ib1, IIa, and IIb, tumor size &lt;40 mm in diameter (assessed by T2-weighted magnetic resonance imaging), and no pelvic/para-aortic lymphadenopathy. The treatment protocol consisted of whole-pelvis external beam radiotherapy (EBRT) of 20 Gy/10 fractions, pelvic EBRT with midline block of 30 Gy/15 fractions, and HDR-ICBT of 24 Gy/4 fractions (at point A). The cumulative biologically effective dose (BED) was 62 Gy10 (α/β = 10) at point A. The primary endpoint was the 2-year pelvic disease progression-free (PDPF) rate. All patients received a radiotherapy quality assurance review. Results Between September 2004 and July 2007, 60 eligible patients were enrolled. Thirty-six patients were assessed with FIGO stage Ib1; 12 patients with stage IIa; and 12 patients with stage IIb. Median tumor diameter was 28 mm (range, 6–39 mm). Median overall treatment time was 43 days. Median follow-up was 49 months (range, 7–72 months). Seven patients developed recurrences: 3 patients had pelvic recurrences (2 central, 1 nodal), and 4 patients had distant metastases. The 2-year PDPF was 96% (95% confidence interval [CI], 92%–100%). The 2-year disease-free and overall survival rates were 90% (95% CI, 82%–98%) and 95% (95% CI, 89%–100%), respectively. The 2-year late complication rates (according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer of Grade ≥1) were 18% (95% CI, 8%–28%) for large intestine/rectum, 4% (95% CI, 0%–8%) for small intestine, and 0% for bladder. No Grade ≥3 cases were observed for genitourinary/gastrointestinal late complications. Conclusions These results suggest that definitive radiotherapy using HDR-ICBT with a low cumulative dose schedule (BED, 62 Gy10 at point A) can provide excellent local control without severe toxicity in nonbulky (&lt;4-cm) early-stage cervical cancer.</description><identifier>ISSN: 0360-3016</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/j.ijrobp.2011.01.022</identifier><identifier>PMID: 21470794</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; BEAMS ; BLADDER ; BRACHYTHERAPY ; Brachytherapy - methods ; Carcinoma of the cervix ; Carcinoma, Squamous Cell - pathology ; Carcinoma, Squamous Cell - radiotherapy ; Carcinoma, Squamous Cell - secondary ; CARCINOMAS ; Disease-Free Survival ; DOSE RATES ; Dose response ; Dose-Response Relationship, Radiation ; Female ; GYNECOLOGY ; Hematology, Oncology and Palliative Medicine ; High-dose-rate ; Humans ; Intracavitary brachytherapy ; METASTASES ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; NMR IMAGING ; PATIENTS ; PELVIS ; Prospective Studies ; QUALITY ASSURANCE ; RADIATION DOSES ; Radiology ; RADIOLOGY AND NUCLEAR MEDICINE ; Radiotherapy ; RECTUM ; Rectum - radiation effects ; Relative Biological Effectiveness ; SCHEDULES ; SMALL INTESTINE ; TOXICITY ; Tumor Burden ; Urinary Bladder - radiation effects ; Uterine Cervical Neoplasms - pathology ; Uterine Cervical Neoplasms - radiotherapy ; Young Adult</subject><ispartof>International journal of radiation oncology, biology, physics, 2012, Vol.82 (1), p.e49-e56</ispartof><rights>Elsevier Inc.</rights><rights>2012 Elsevier Inc.</rights><rights>Copyright © 2012 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4382-e5962fb53d78b49f4b9cef718d9da93d77153cb6e449e7d871eee67c0b2d059e3</citedby><cites>FETCH-LOGICAL-c4382-e5962fb53d78b49f4b9cef718d9da93d77153cb6e449e7d871eee67c0b2d059e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0360301611001532$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,4010,27900,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21470794$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://www.osti.gov/biblio/22055948$$D View this record in Osti.gov$$Hfree_for_read</backlink></links><search><creatorcontrib>Toita, Takafumi, M.D., Ph.D</creatorcontrib><creatorcontrib>Kato, Shingo, M.D., Ph.D</creatorcontrib><creatorcontrib>Niibe, Yuzuru, M.D., Ph.D</creatorcontrib><creatorcontrib>Ohno, Tatsuya, M.D., Ph.D</creatorcontrib><creatorcontrib>Kazumoto, Tomoko, M.D., Ph.D</creatorcontrib><creatorcontrib>Kodaira, Takeshi, M.D., Ph.D</creatorcontrib><creatorcontrib>Kataoka, Masaaki, M.D., Ph.D</creatorcontrib><creatorcontrib>Shikama, Naoto, M.D., Ph.D</creatorcontrib><creatorcontrib>Kenjo, Masahiro, M.D., Ph.D</creatorcontrib><creatorcontrib>Tokumaru, Sunao, M.D</creatorcontrib><creatorcontrib>Yamauchi, Chikako, M.D., Ph.D</creatorcontrib><creatorcontrib>Suzuki, Osamu, M.D., Ph.D</creatorcontrib><creatorcontrib>Sakurai, Hideyuki, M.D., Ph.D</creatorcontrib><creatorcontrib>Numasaki, Hodaka, Ph.D</creatorcontrib><creatorcontrib>Teshima, Teruki, M.D., Ph.D</creatorcontrib><creatorcontrib>Oguchi, Masahiko, M.D., Ph.D</creatorcontrib><creatorcontrib>Kagami, Yoshikazu, M.D., Ph.D</creatorcontrib><creatorcontrib>Nakano, Takashi, M.D., Ph.D</creatorcontrib><creatorcontrib>Hiraoka, Masahiro, M.D., Ph.D</creatorcontrib><creatorcontrib>Mitsuhashi, Norio, M.D., Ph.D</creatorcontrib><title>Prospective Multi-Institutional Study of Definitive Radiotherapy With High-Dose-Rate Intracavitary Brachytherapy in Patients With Nonbulky (&lt;4-cm) Stage I and II Uterine Cervical Cancer (JAROG0401/JROSG04-2)</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>Purpose To determine the efficacy of a definitive radiotherapy protocol using high-dose-rate intracavitary brachytherapy (HDR-ICBT) with a low cumulative dose schedule in nonbulky early-stage cervical cancer patients, we conducted a prospective multi-institutional study. Methods and Materials Eligible patients had squamous cell carcinoma of the intact uterine cervix, Federation of Gynecologic Oncology and Obstetrics (FIGO) stages Ib1, IIa, and IIb, tumor size &lt;40 mm in diameter (assessed by T2-weighted magnetic resonance imaging), and no pelvic/para-aortic lymphadenopathy. The treatment protocol consisted of whole-pelvis external beam radiotherapy (EBRT) of 20 Gy/10 fractions, pelvic EBRT with midline block of 30 Gy/15 fractions, and HDR-ICBT of 24 Gy/4 fractions (at point A). The cumulative biologically effective dose (BED) was 62 Gy10 (α/β = 10) at point A. The primary endpoint was the 2-year pelvic disease progression-free (PDPF) rate. All patients received a radiotherapy quality assurance review. Results Between September 2004 and July 2007, 60 eligible patients were enrolled. Thirty-six patients were assessed with FIGO stage Ib1; 12 patients with stage IIa; and 12 patients with stage IIb. Median tumor diameter was 28 mm (range, 6–39 mm). Median overall treatment time was 43 days. Median follow-up was 49 months (range, 7–72 months). Seven patients developed recurrences: 3 patients had pelvic recurrences (2 central, 1 nodal), and 4 patients had distant metastases. The 2-year PDPF was 96% (95% confidence interval [CI], 92%–100%). The 2-year disease-free and overall survival rates were 90% (95% CI, 82%–98%) and 95% (95% CI, 89%–100%), respectively. The 2-year late complication rates (according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer of Grade ≥1) were 18% (95% CI, 8%–28%) for large intestine/rectum, 4% (95% CI, 0%–8%) for small intestine, and 0% for bladder. No Grade ≥3 cases were observed for genitourinary/gastrointestinal late complications. Conclusions These results suggest that definitive radiotherapy using HDR-ICBT with a low cumulative dose schedule (BED, 62 Gy10 at point A) can provide excellent local control without severe toxicity in nonbulky (&lt;4-cm) early-stage cervical cancer.</description><subject>Adult</subject><subject>Aged</subject><subject>BEAMS</subject><subject>BLADDER</subject><subject>BRACHYTHERAPY</subject><subject>Brachytherapy - methods</subject><subject>Carcinoma of the cervix</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Carcinoma, Squamous Cell - radiotherapy</subject><subject>Carcinoma, Squamous Cell - secondary</subject><subject>CARCINOMAS</subject><subject>Disease-Free Survival</subject><subject>DOSE RATES</subject><subject>Dose response</subject><subject>Dose-Response Relationship, Radiation</subject><subject>Female</subject><subject>GYNECOLOGY</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>High-dose-rate</subject><subject>Humans</subject><subject>Intracavitary brachytherapy</subject><subject>METASTASES</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local</subject><subject>Neoplasm Staging</subject><subject>NMR IMAGING</subject><subject>PATIENTS</subject><subject>PELVIS</subject><subject>Prospective Studies</subject><subject>QUALITY ASSURANCE</subject><subject>RADIATION DOSES</subject><subject>Radiology</subject><subject>RADIOLOGY AND NUCLEAR MEDICINE</subject><subject>Radiotherapy</subject><subject>RECTUM</subject><subject>Rectum - radiation effects</subject><subject>Relative Biological Effectiveness</subject><subject>SCHEDULES</subject><subject>SMALL INTESTINE</subject><subject>TOXICITY</subject><subject>Tumor Burden</subject><subject>Urinary Bladder - radiation effects</subject><subject>Uterine Cervical Neoplasms - pathology</subject><subject>Uterine Cervical Neoplasms - radiotherapy</subject><subject>Young Adult</subject><issn>0360-3016</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkt1u0zAYhiMEYmVwBwhZ4qQ7SGc7zp-EJo0Otk6DTi0TnFmO82V1l9rFdirlKrklHLJxwAmSpVjW8_3kfd8oekvwjGCSnW5namtNtZ9RTMgMh0Pps2hCiryMkzT98Tya4CTDcRLgo-iVc1uMA5mzl9ERJSzHeckm0a9ba9wepFcHQF-61qt4oZ1XvvPKaNGite_qHpkGXUCjtPrDrUStjN-AFfsefVd-g67U_Sa-MA7ilfCAFtpbIcVBeWF79DHcN_0TrzS6FV6B9m6s_Wp01bUPPZp-YLHcnYSR4j70QELXaLFAdx6s0oDmYA9KhpXmQkuwaHp9vlpeYobJ6fVquQ63mJ68jl40onXw5vF7HN19_vRtfhXfLC8X8_ObWLKkoDGkZUabKk3qvKhY2bCqlNDkpKjLWpThNSdpIqsMGCshr4ucAECWS1zRGqclJMfR-7GvCWJxJ5UHuZFG6yAlpxSnacmKQE1Ham_Nzw6c5zvlJLSt0GA6x0mSZiVNSTagbERlMMRZaPjeql2QjxPMB8P5lo-G88FwjsOhNJS9e5zQVTuo_xY9ORyAsxGAoMZBgR2WhSBgreywa23U_yb820C2IQjBiAfowW1NZ0NOwr9wRznm6yF0Q-YICXFLE5r8Brn50tw</recordid><startdate>2012</startdate><enddate>2012</enddate><creator>Toita, Takafumi, M.D., Ph.D</creator><creator>Kato, Shingo, M.D., Ph.D</creator><creator>Niibe, Yuzuru, M.D., Ph.D</creator><creator>Ohno, Tatsuya, M.D., Ph.D</creator><creator>Kazumoto, Tomoko, M.D., Ph.D</creator><creator>Kodaira, Takeshi, M.D., Ph.D</creator><creator>Kataoka, Masaaki, M.D., Ph.D</creator><creator>Shikama, Naoto, M.D., Ph.D</creator><creator>Kenjo, Masahiro, M.D., Ph.D</creator><creator>Tokumaru, Sunao, M.D</creator><creator>Yamauchi, Chikako, M.D., Ph.D</creator><creator>Suzuki, Osamu, M.D., Ph.D</creator><creator>Sakurai, Hideyuki, M.D., Ph.D</creator><creator>Numasaki, Hodaka, Ph.D</creator><creator>Teshima, Teruki, M.D., Ph.D</creator><creator>Oguchi, Masahiko, M.D., Ph.D</creator><creator>Kagami, Yoshikazu, M.D., Ph.D</creator><creator>Nakano, Takashi, M.D., Ph.D</creator><creator>Hiraoka, Masahiro, M.D., Ph.D</creator><creator>Mitsuhashi, Norio, M.D., Ph.D</creator><general>Elsevier Inc</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>7U7</scope><scope>C1K</scope><scope>OTOTI</scope></search><sort><creationdate>2012</creationdate><title>Prospective Multi-Institutional Study of Definitive Radiotherapy With High-Dose-Rate Intracavitary Brachytherapy in Patients With Nonbulky (&lt;4-cm) Stage I and II Uterine Cervical Cancer (JAROG0401/JROSG04-2)</title><author>Toita, Takafumi, M.D., Ph.D ; Kato, Shingo, M.D., Ph.D ; Niibe, Yuzuru, M.D., Ph.D ; Ohno, Tatsuya, M.D., Ph.D ; Kazumoto, Tomoko, M.D., Ph.D ; Kodaira, Takeshi, M.D., Ph.D ; Kataoka, Masaaki, M.D., Ph.D ; Shikama, Naoto, M.D., Ph.D ; Kenjo, Masahiro, M.D., Ph.D ; Tokumaru, Sunao, M.D ; Yamauchi, Chikako, M.D., Ph.D ; Suzuki, Osamu, M.D., Ph.D ; Sakurai, Hideyuki, M.D., Ph.D ; Numasaki, Hodaka, Ph.D ; Teshima, Teruki, M.D., Ph.D ; Oguchi, Masahiko, M.D., Ph.D ; Kagami, Yoshikazu, M.D., Ph.D ; Nakano, Takashi, M.D., Ph.D ; Hiraoka, Masahiro, M.D., Ph.D ; Mitsuhashi, Norio, M.D., Ph.D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4382-e5962fb53d78b49f4b9cef718d9da93d77153cb6e449e7d871eee67c0b2d059e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>BEAMS</topic><topic>BLADDER</topic><topic>BRACHYTHERAPY</topic><topic>Brachytherapy - methods</topic><topic>Carcinoma of the cervix</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>Carcinoma, Squamous Cell - radiotherapy</topic><topic>Carcinoma, Squamous Cell - secondary</topic><topic>CARCINOMAS</topic><topic>Disease-Free Survival</topic><topic>DOSE RATES</topic><topic>Dose response</topic><topic>Dose-Response Relationship, Radiation</topic><topic>Female</topic><topic>GYNECOLOGY</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>High-dose-rate</topic><topic>Humans</topic><topic>Intracavitary brachytherapy</topic><topic>METASTASES</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local</topic><topic>Neoplasm Staging</topic><topic>NMR IMAGING</topic><topic>PATIENTS</topic><topic>PELVIS</topic><topic>Prospective Studies</topic><topic>QUALITY ASSURANCE</topic><topic>RADIATION DOSES</topic><topic>Radiology</topic><topic>RADIOLOGY AND NUCLEAR MEDICINE</topic><topic>Radiotherapy</topic><topic>RECTUM</topic><topic>Rectum - radiation effects</topic><topic>Relative Biological Effectiveness</topic><topic>SCHEDULES</topic><topic>SMALL INTESTINE</topic><topic>TOXICITY</topic><topic>Tumor Burden</topic><topic>Urinary Bladder - radiation effects</topic><topic>Uterine Cervical Neoplasms - pathology</topic><topic>Uterine Cervical Neoplasms - radiotherapy</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Toita, Takafumi, M.D., Ph.D</creatorcontrib><creatorcontrib>Kato, Shingo, M.D., Ph.D</creatorcontrib><creatorcontrib>Niibe, Yuzuru, M.D., Ph.D</creatorcontrib><creatorcontrib>Ohno, Tatsuya, M.D., Ph.D</creatorcontrib><creatorcontrib>Kazumoto, Tomoko, M.D., Ph.D</creatorcontrib><creatorcontrib>Kodaira, Takeshi, M.D., Ph.D</creatorcontrib><creatorcontrib>Kataoka, Masaaki, M.D., Ph.D</creatorcontrib><creatorcontrib>Shikama, Naoto, M.D., Ph.D</creatorcontrib><creatorcontrib>Kenjo, Masahiro, M.D., Ph.D</creatorcontrib><creatorcontrib>Tokumaru, Sunao, M.D</creatorcontrib><creatorcontrib>Yamauchi, Chikako, M.D., Ph.D</creatorcontrib><creatorcontrib>Suzuki, Osamu, M.D., Ph.D</creatorcontrib><creatorcontrib>Sakurai, Hideyuki, M.D., Ph.D</creatorcontrib><creatorcontrib>Numasaki, Hodaka, Ph.D</creatorcontrib><creatorcontrib>Teshima, Teruki, M.D., Ph.D</creatorcontrib><creatorcontrib>Oguchi, Masahiko, M.D., Ph.D</creatorcontrib><creatorcontrib>Kagami, Yoshikazu, M.D., Ph.D</creatorcontrib><creatorcontrib>Nakano, Takashi, M.D., Ph.D</creatorcontrib><creatorcontrib>Hiraoka, Masahiro, M.D., Ph.D</creatorcontrib><creatorcontrib>Mitsuhashi, Norio, M.D., Ph.D</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>OSTI.GOV</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Toita, Takafumi, M.D., Ph.D</au><au>Kato, Shingo, M.D., Ph.D</au><au>Niibe, Yuzuru, M.D., Ph.D</au><au>Ohno, Tatsuya, M.D., Ph.D</au><au>Kazumoto, Tomoko, M.D., Ph.D</au><au>Kodaira, Takeshi, M.D., Ph.D</au><au>Kataoka, Masaaki, M.D., Ph.D</au><au>Shikama, Naoto, M.D., Ph.D</au><au>Kenjo, Masahiro, M.D., Ph.D</au><au>Tokumaru, Sunao, M.D</au><au>Yamauchi, Chikako, M.D., Ph.D</au><au>Suzuki, Osamu, M.D., Ph.D</au><au>Sakurai, Hideyuki, M.D., Ph.D</au><au>Numasaki, Hodaka, Ph.D</au><au>Teshima, Teruki, M.D., Ph.D</au><au>Oguchi, Masahiko, M.D., Ph.D</au><au>Kagami, Yoshikazu, M.D., Ph.D</au><au>Nakano, Takashi, M.D., Ph.D</au><au>Hiraoka, Masahiro, M.D., Ph.D</au><au>Mitsuhashi, Norio, M.D., Ph.D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective Multi-Institutional Study of Definitive Radiotherapy With High-Dose-Rate Intracavitary Brachytherapy in Patients With Nonbulky (&lt;4-cm) Stage I and II Uterine Cervical Cancer (JAROG0401/JROSG04-2)</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>2012</date><risdate>2012</risdate><volume>82</volume><issue>1</issue><spage>e49</spage><epage>e56</epage><pages>e49-e56</pages><issn>0360-3016</issn><eissn>1879-355X</eissn><abstract>Purpose To determine the efficacy of a definitive radiotherapy protocol using high-dose-rate intracavitary brachytherapy (HDR-ICBT) with a low cumulative dose schedule in nonbulky early-stage cervical cancer patients, we conducted a prospective multi-institutional study. Methods and Materials Eligible patients had squamous cell carcinoma of the intact uterine cervix, Federation of Gynecologic Oncology and Obstetrics (FIGO) stages Ib1, IIa, and IIb, tumor size &lt;40 mm in diameter (assessed by T2-weighted magnetic resonance imaging), and no pelvic/para-aortic lymphadenopathy. The treatment protocol consisted of whole-pelvis external beam radiotherapy (EBRT) of 20 Gy/10 fractions, pelvic EBRT with midline block of 30 Gy/15 fractions, and HDR-ICBT of 24 Gy/4 fractions (at point A). The cumulative biologically effective dose (BED) was 62 Gy10 (α/β = 10) at point A. The primary endpoint was the 2-year pelvic disease progression-free (PDPF) rate. All patients received a radiotherapy quality assurance review. Results Between September 2004 and July 2007, 60 eligible patients were enrolled. Thirty-six patients were assessed with FIGO stage Ib1; 12 patients with stage IIa; and 12 patients with stage IIb. Median tumor diameter was 28 mm (range, 6–39 mm). Median overall treatment time was 43 days. Median follow-up was 49 months (range, 7–72 months). Seven patients developed recurrences: 3 patients had pelvic recurrences (2 central, 1 nodal), and 4 patients had distant metastases. The 2-year PDPF was 96% (95% confidence interval [CI], 92%–100%). The 2-year disease-free and overall survival rates were 90% (95% CI, 82%–98%) and 95% (95% CI, 89%–100%), respectively. The 2-year late complication rates (according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer of Grade ≥1) were 18% (95% CI, 8%–28%) for large intestine/rectum, 4% (95% CI, 0%–8%) for small intestine, and 0% for bladder. No Grade ≥3 cases were observed for genitourinary/gastrointestinal late complications. Conclusions These results suggest that definitive radiotherapy using HDR-ICBT with a low cumulative dose schedule (BED, 62 Gy10 at point A) can provide excellent local control without severe toxicity in nonbulky (&lt;4-cm) early-stage cervical cancer.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>21470794</pmid><doi>10.1016/j.ijrobp.2011.01.022</doi><oa>free_for_read</oa></addata></record>
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issn 0360-3016
1879-355X
language eng
recordid cdi_osti_scitechconnect_22055948
source MEDLINE; Elsevier ScienceDirect Journals
subjects Adult
Aged
BEAMS
BLADDER
BRACHYTHERAPY
Brachytherapy - methods
Carcinoma of the cervix
Carcinoma, Squamous Cell - pathology
Carcinoma, Squamous Cell - radiotherapy
Carcinoma, Squamous Cell - secondary
CARCINOMAS
Disease-Free Survival
DOSE RATES
Dose response
Dose-Response Relationship, Radiation
Female
GYNECOLOGY
Hematology, Oncology and Palliative Medicine
High-dose-rate
Humans
Intracavitary brachytherapy
METASTASES
Middle Aged
Neoplasm Recurrence, Local
Neoplasm Staging
NMR IMAGING
PATIENTS
PELVIS
Prospective Studies
QUALITY ASSURANCE
RADIATION DOSES
Radiology
RADIOLOGY AND NUCLEAR MEDICINE
Radiotherapy
RECTUM
Rectum - radiation effects
Relative Biological Effectiveness
SCHEDULES
SMALL INTESTINE
TOXICITY
Tumor Burden
Urinary Bladder - radiation effects
Uterine Cervical Neoplasms - pathology
Uterine Cervical Neoplasms - radiotherapy
Young Adult
title Prospective Multi-Institutional Study of Definitive Radiotherapy With High-Dose-Rate Intracavitary Brachytherapy in Patients With Nonbulky (<4-cm) Stage I and II Uterine Cervical Cancer (JAROG0401/JROSG04-2)
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