UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003651 |
|---|---|
| Receipt number | R000004420 |
| Scientific Title | A Randomized Phase III Trial of Adjuvant Chemotherapy with UFT following Curative Radiation Therapy for Locally Advanced Cervical Cancer |
| Date of disclosure of the study information | 2010/05/24 |
| Last modified on | 2023/05/31 15:00:21 |
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Basic information
Public title
A Randomized Phase III Trial of Adjuvant Chemotherapy with UFT following Curative Radiation Therapy for Locally Advanced Cervical Cancer
Acronym
A Randomized Trial of Adjuvant Chemotherapy with UFT following Curative Therapy for Locally Advanced Cervical Cancer
Scientific Title
A Randomized Phase III Trial of Adjuvant Chemotherapy with UFT following Curative Radiation Therapy for Locally Advanced Cervical Cancer
Scientific Title:Acronym
A Randomized Trial of Adjuvant Chemotherapy with UFT following Curative Therapy for Locally Advanced Cervical Cancer
Region
| Japan |
Condition
Condition
Stage Ib2-IVa cervical cancer with Curative Radiation Therapy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of Adjuvant Chemotherapy with UFT following Curative Therapy for patients with StageIb2-IVa cervical cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall Suvival/Adverse event/Quality of Life/Cost effectiveness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Observation
Interventions/Control_2
UFT 300 or 400mg/Day
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Pathologicaly confirmed cervical cancer(squamous cell carcinoma,adenosquamous carcinoma,adenocarcinoma)
2)FIGO: Ib2, IIa, IIb, IIIa, IIIb, IVa
3)Patients who have received CCRT within 3-12 weeks and determined to be PR or CR by CT or MRI.
4)Age: 20 years old-75 years old
5)Performance status: ECOG 0-2
6)Adequate organ functions.
7)Patients who have signed to an approved informed consent.
Key exclusion criteria
1)Patients who have received hysterectomy after radiation therapy.
2)Patients with uterine stump cancer.
3)Patients who have received NAC.
4)Patients with active infection.
5)Patients who have myocardial infarction or unstable angina or uncontrolled arrhythmia within 6 months.
6)Patients with severe complications (uncontrolled hypertension,uncontrolled diabetes,bleeding tendency,or rheumatology).
7)Patients who have had any other cancer within the past 5 years.
8)Patients with watery diarrhea.
9)Patients with psychiatric disease.
10)Patients who are pregnant or breast feeding.
11)Patients who have a history of hypersensitivity to UFT
12)Patients who are considered to be inappropriate for this study judged by the treating physician
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Fujiwara |
Organization
Saitama Medical University International Medical Center
Division name
Gynecologic Oncology
Zip code
350-1298
Address
1397-1 Yamane,Hidaka-City Saitama
TEL
042-984-4111
fujawara@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Fujiwara |
Organization
GOTIC002 Coordinating Office
Division name
Saitama Medical University International Medical Center
Zip code
350-1298
Address
1397-1 Yamane,Hidaka-City Saitama
TEL
042-984-4111
Homepage URL
fujawara@saitama-med.ac.jp
Sponsor or person
Institute
Gynecologic Oncology Trial and Investigation Consortium
Institute
Department
Personal name
Funding Source
Organization
Gynecologic Oncology Trial and Investigation Consortium
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Certified Review Board
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
042-984-4122
tokutei@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180244
Org. issuing International ID_1
Japan Registry of Clinical Trials(jRCT)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター（埼玉県）、
鳥取大学医学部附属病院（鳥取県）、
久留米大学病院（福岡県）、
埼玉医科大学総合医療センター（埼玉県）、
埼玉県立がんセンター（埼玉県）、
筑波大学附属病院（茨城県）、
獨協医科大学病院（栃木県）、
自治医科大学附属病院（栃木県）、
群馬大学医学部附属病院（群馬県）、
立正佼成会附属佼成病院（東京都）、
群馬県立がんセンター（群馬県）、
鳥取市立病院（鳥取県）、
九州大学病院（福岡県）、
四国がんセンター（愛媛県）、
順天堂大学医学部附属順天堂医院（東京都）、
徳島大学病院（徳島県）、
広島市立広島市民病院（広島県）、
県立広島病院（広島県）、
東京慈恵会医科大学附属病院（東京都）、
高崎総合医療センター（群馬県）、
聖マリアンナ医科大学病院（神奈川県）、
東京医科歯科大学医学部附属病院（東京都）、
千葉大学医学部附属病院（千葉県）、
大阪大学医学部附属病院（大阪府）、
愛媛大学医学部附属病院（愛媛県）、
東京慈恵会医科大学附属第三病院（東京都）、
杏林大学医学部附属病院（東京都）、
鹿児島大学病院（鹿児島県）、
北海道大学病院（北海道）、
琉球大学病院（沖縄県）、
東京慈恵会医科大学附属柏病院（千葉県）、
兵庫県立がんセンター（兵庫県）、
香川県立中央病院（香川県）、
鹿児島医療センター（鹿児島県）、
聖マリア病院（福岡県）、
茨城県立中央病院（茨城県）、
熊本大学医学部附属病院（熊本県）、
北里大学病院（神奈川県）、
聖隷浜松病院（静岡県）、
旭川医科大学病院（北海道）、
三重大学医学部附属病院（三重県）、
岩手医科大学附属病院（岩手県）、
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004420
