UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Title of the study (Brief title)	Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Region	Japan

Condition
Condition	Postoperative uterine cervical cancer patients with high-risk prognostic factors
Classification by specialty	Obsterics and gynecology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the effecacy and safety of treatment with intensity modulated radiation therapy and weekly 40mg/m2 cisplatin on postoperative uterine cervical cancer patients with high-risk prognostic factors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	3-year relapse free survival
Key secondary outcomes	Overall survival, locoregional-relapse free survival, proportion of >= Grade 3 lower gastrointestinal complication, proportion of lower limb edema, adverse events, serious adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	Cisplatin (40 mg/m2) is administered intravenously on a weekly basis for 5 weeks during the course of IMRT. The IMRT dose is 50.4 Gy/28 fr.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	1. Clinical stage IB1, IB2, IIA1, IIA2, IIB cervical cancer (FIGO 2008) 2. Histological findings of squamous cell carcinoma (keratinizing or non-keratinizing), adenocarcinoma (endocervical mucinous type, intestinal mucinous type or endometrial type), or adenosquamous carcinoma 3. Histologically confirmed positive pelvic lymph nodes and/or parametrial invasion. 4. No distant metastasis in chest to pelvic contrast enhanced CT within 56 days before surgery 5. In case with node dissection except pelvic lesion, there is no positive node in these lesions. 6. Radical hysterectomy is performed and the following (i) to (v) are fulfilled. i) R0 resection ii) Negative margin is confirmed by pathological findings. iii) At least 20 lymph nodes dissection confirmed by pathological findings. iv) Ligamentum cardinale is removed. v) The cut length of paracolpium and vagina is 2cm or more. 7. Aged 20 to 70 years old 8. ECOG performance status of 0 or 1 9. Within 28 to 56 days after surgery 10. No following prior treatment i) Surgery except for cervical conization or radical hysterectomy for uterine cervical cancer ii) Surgery for lower abdominal or pelvic malignancy iii) Radiation therapy or chemotherapy for other malignancies 11. Adequate organ functions 12. Written informed consent
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 2) Active systemic infections to be treated. 3) Body temperature of 38 or more degrees Celsius 4) Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding 5) Severe psychiatric disease 6) Continuous systemic steroid treatment 7) Insulin-dependent or uncontrolled diabetes mellitus 8) Uncontrolled hypertension 9) Unstable angina, or history of myocardial infarction within 6 months 10) HBs antigen or HCV antibody positive 11) HIV antibody positive 12) Interstitial pneumonitis, lung fibrosis or severe emphysema on chest CT
Target sample size	220

Research contact person
Name of lead principal investigator	Takafumi Toita
Organization	Okinawa Prefectural Chubu Hospital
Division name	Department of Radiology
Address	Miyazato 281 Uruma, Okinawa, 904-2293, Japan
TEL	098-973-4111ext3920
Email	b983255@med.u-ryukyu.ac.jp

Public contact
Name of contact person	Fumiaki Isohashi
Organization	JCOG1402 Coordinating Office
Division name	Osaka University Graduate School of Medicine
Address	2-2(D10) Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3482
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学病院（北海道） 札幌医科大学（北海道） 岩手医科大学（岩手県） 東北大学病院（宮城県） 筑波大学医学医療系（茨城県） 茨城県立中央病院・茨城県地域がんセンター（茨城県） 群馬大学医学部附属病院（群馬県） 群馬県立がんセンター（群馬県） 埼玉県立がんセンター（埼玉県） 埼玉医科大学総合医療センター（埼玉県） 千葉県がんセンター（千葉県） 千葉大学医学部（千葉県） 東京慈恵会医科大学附属柏病院（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 慶應義塾大学病院（東京都） 昭和大学病院（東京都） がん研究会有明病院（東京都） 東京大学医学部（東京都） 東京慈恵会医科大学附属病院（東京都） 順天堂大学医学部附属順天堂医院（東京都） NTT東日本関東病院（東京都） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 北里大学医学部（神奈川県） 信州大学医学部（長野県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 名古屋大学医学部（愛知県） 京都大学医学部附属病院（京都府） 京都府立医科大学（京都府） 大阪大学医学部（大阪府） 近畿大学医学部（大阪府） 大阪国際がんセンター（大阪府） 大阪市立総合医療センター（大阪府） 大阪医科大学（大阪府） 神戸市立医療センター中央市民病院（兵庫県） 兵庫県立がんセンター（兵庫県） 鳥取大学医学部（鳥取県） 国立病院機構呉医療センター・中国がんセンター（広島県） 国立病院機構四国がんセンター（愛媛県） 愛媛大学医学部附属病院（愛媛県） 九州大学病院（福岡県） 国立病院機構九州がんセンター（福岡県） 熊本大学医学部（熊本県） 鹿児島大学病院（鹿児島県） 鹿児島市立病院（鹿児島県） 琉球大学医学部附属病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 04 Month 17 Day
Last follow-up date	2026 Year 10 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 17 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030672