UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II clinical trial of pelvic carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Acronym	Cervix-VI (Protocol 1302)
Scientific Title	A phase I/II clinical trial of pelvic carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Scientific Title:Acronym	Cervix-VI (Protocol 1302)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the saftey and the toxicity of prophylactic radiotherapy of pelvic lymph nodes using carbon ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Acute toxicity 2-year progression free survival
Key secondary outcomes	The ratio of the patients who completed the course Acute and late toxicies Response rate of the local Local control rate Overall survival rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	5 weeks Carbon ion radiotherapy: 72.0 GyE / 20 fractions Chemotherapy: weekly cisplatin 30-40 mg / m2 for 5 weeks.
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	70 years-old >=
Gender	Female
Key inclusion criteria	1. Squamous cell carcinoma of the uterine cervix 2. International Federation of Gynecology and Obstetrics (FIGO) Stage IIB(>= 4 cm in diameter), III, or IVA disease 3. No para-aortic lymph nodes >= 1 cm in minimum diameter on CT images 4. The tumor had to be grossly measurable. 5. Age between 20 and 70 years 6. Performance status 0 - 2 7. Patients with no histories of prior chemotherapy or pelvic radiotherapy for cervical cancer 8. Normal organ function (WBC >= 3000/mm3,Hb >= 10g/dl, Plt>= 100,000/mm3, T-Bil.<= 1.5mg/dl, AST(GOT) and ALT(GPT) <= 100IU/dl, Cre <= 1.5mg/dl, CCR >= 50ml/min, ECG normal or require no treatment 9. Estimated life expectancy of _6 months 10. Written informed consent
Key exclusion criteria	1. Severe complicating illness 2. Active double cancer 3. Rectal invasion 4. History of pelvic radiotherapy 5. History of prior chemotherapy 6. medical, psychological or others reason that primary doctor think ineligible
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Wakatsuki
Organization	National Institute for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL	043-206-3306
Email	wakkun100@yahoo.co.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Wakatsuki
Organization	National Institute for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL	043-206-3306
Homepage URL	http://www.nirs.go.jp/hospital/index.shtml
Email	wakkun100@yahoo.co.jp

Sponsor
Institute	National Institute for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	National Institute for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Institute for Quantum and Radiological Science and Technology
Address	4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
Tel	043-206-3193
Email	genkoba@nirs.go.jp

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	放射線医学総合研究所（千葉県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 17 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	4
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	Terminated
Date of protocol fixation	2013 Year 05 Month 20 Day
Date of IRB	2012 Year 05 Month 23 Day
Anticipated trial start date	2012 Year 06 Month 06 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 15 Day
Last modified on	2021 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012837