UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501)
Title of the study (Brief title)	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	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)
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	Yuzuru Niibe
Organization	Kitasato University School of Medicine
Division name	Dept. of Radiology and Radiation Oncology
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

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2005 Year 05 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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