UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025688
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email joe-n@hkg.odn.ne.jp

Sponsor
Institute Kitasato Gynecologic Radiatoin Oncology Group (KGROG)
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029552

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.