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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027017
Receipt No. R000030672
Scientific Title Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Date of disclosure of the study information 2017/04/17
Last modified on 2018/04/19

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Basic information
Public title Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Acronym Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Scientific Title Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takafumi Toita
Organization Okinawa Prefectural Chubu Hospital
Division name Department of Radiology
Zip code
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
1st name
Middle name
Last name Fumiaki Isohashi
Organization JCOG1402 Coordinating Office
Division name Osaka University Graduate School of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 01 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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