UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Title of the study (Brief title)	Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Region	Japan

Condition
Condition	cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of concurrent daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Overall survival by histology Overall survival by age Adverse effects

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	A total dose of 50 Gy was delivered in 25 daily fractions of2.0 Gy, administered on 5 days a week CDDP: 8 mg/m2/day weekday x 25
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	Not applicable
Gender	Female
Key inclusion criteria	1) Patients with stage IIA to IIIB cervical cancer according to the International Federation of Gynecologyand Obstetrics, 2) Cervical carcinoma of the non- small cell type (squamous, adenosquamous, and adenocarcinoma), were selected. 3) no previous chemotherapy or radiotherapy 4) ECOG performance status 0-2 5) Leukocyte count of 3,000/mm3 or higher, neutrophil count of 2,000/mm3 or higher, platelet count of 100,000/mm3 or higher, serum creatinine 1.5 mg/dl or less 6)) normal chest radiograph and electrocardiogram.
Key exclusion criteria	1) positive para aortic lymph node swelling 2) severe systemic or uncontrolled disease (uncontrolled diabetes mellitus or hypertension) 3) severe infection that precluded the use of chemotherapy 4) preexisting neuropathy from any cause, pregnancy or lactation 5) mental illness 6) previous or concomitant malignancies
Target sample size	65

Research contact person
Name of lead principal investigator	Akira Mitsuhashi
Organization	Graduate School of Medicine, Chiba University
Division name	Reproductive Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Email	antira@faculty.chiba-u.jp

Public contact
Name of contact person	AKIra Mitsuhashi
Organization	Graduate School of Medicine, Chiba University
Division name	Reproductive Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	antira@faculty.chbia-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2003 Year 01 Month 10 Day
Anticipated trial start date	2003 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2016 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028049