UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025688 |
|---|---|
| Receipt number | R000029552 |
| Scientific Title | Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501) |
| Date of disclosure of the study information | 2017/01/15 |
| Last modified on | 2017/12/01 08:29:36 |
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Basic information
Public title
Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501)
Acronym
Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: KGROG0501
Scientific Title
Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501)
Scientific Title:Acronym
Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: KGROG0501
Region
| Japan |
Condition
Condition
Locally Advanced Uterine Cervical Carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of chemoradiotherapy using nedaplatin for locally advanced uterine cervical carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-year overall survival
Key secondary outcomes
initial tumor response, protocol completion rate, 2-year overall survival rate, 2- and 3-year overall survival rate, 3-year loco-regional contorol rate, pattern of failure(initial site), acute adverse events(based on CTCAE ver3.0: hematological and non-hematological), late adverse events (based on RTOG/EORTC late radiatoin morbidity scoring schema: small instestine/colon, rectum, bladder)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemoradiotherapy
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)pathologically proven squamous cell carcinoma or adenocarcinoma, 2)clinical FIGO stage Ib, IIa, IIb with bulky tumor (40mm and/or more assessed by magnetic resonance imaging) or pelvic lymph node sweelling (10mm and/or more assessed by computed tomography); Clinical FIGO stage IIIa, IIIb or IVa, 3)Age: 20-75 years, 4) Pefomance status (Eastern Cooperative Oncology Group): 0-2, 5)No prior radiatoin therapy for abdomen and pelvis, 6)Adequate functoin of bone marrow, kidney and liver (white blood cell count >= 2500 mm3, neutrophil >= 1000 mm3, hemoglobin >= 8.0g/dl, platelet count >= 75,000 mm3, creatinine <= 2.0 mg/dl, 24h-Ccr >= 60 ml/min, GOT and GPT <= 2 times of the upper limit of normal value at our institution, T.Bil < 2 times of the upper limit of normal at our institution), 7) Written informed consent
Key exclusion criteria
1)Active other cancers except carcinoma in situ or contorolled for more than 2 years, 2)Use of long-term and continuous steroid, 3)Serios complications (heart disease within 3 months, chronic heart failure, neurovascular disease wtih 3 months, uncontrolled disease), 4) para-aortic lymph node swelling (>= 10mm assessed by abdominal computed tomography), 5)Judged to be ineligible for this protocol by the attending physicians
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazushige Hayakawa, Nobuya Unno |
Organization
Kitasato University School of Medicine
Division name
Dept. of Radiology and Radiation Oncology (Kazushige Hayakawa), Dept. of Obstetrics and Gynecology (Nobuya Unno)
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374
TEL
042-778-8111
hayakazu@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuzuru Niibe |
Organization
Kitasato University School of Medicine
Division name
Dept. of Radiology and Radiation Oncology
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374
TEL
042-778-8111
Homepage URL
joe-n@hkg.odn.ne.jp
Sponsor or person
Institute
Kitasato Gynecologic Radiatoin Oncology Group (KGROG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kitasato University
IRB Contact (For public release)
Organization
Address
Tel
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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2005 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 15 | Day |
Last modified on
| 2017 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029552
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