UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027578
Receipt No. R000031617
Scientific Title 3D-Image-guided brachytherapy for Locally Advanced Cervical Cancer (Cervix-V)
Date of disclosure of the study information 2017/05/31
Last modified on 2017/05/31

* 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 3D-Image-guided brachytherapy for Locally Advanced Cervical Cancer (Cervix-V)
Acronym FNCA Cervix-V
Scientific Title 3D-Image-guided brachytherapy for Locally Advanced Cervical Cancer (Cervix-V)
Scientific Title:Acronym FNCA Cervix-V
Region
Japan Asia(except Japan)

Condition
Condition Squamous cell carcinoma of the uterine cervix, Stage IIB (>4 cm in diameter) and IIIB disease
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy of 3D-image guided radiation therapy (3D-IGBT) for patients with locally advanced cervical cancer in FNCA countries.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-year overall survival rate
Key secondary outcomes 2-year local control rate, acute and late toxicities

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Stage IIB (>=4 cm in diameter) and IIIB disease (FIGO 2008)
3. Age; 20-70 years
4. PS; WHO 0-2
5. No prior chemotherapy, radiotherapy, and surgery to the pelvis
6. Life expectancy; longer than 6 months
7. Adequate bone marrow, hepatic, and renal functions;
WBC>=3000/mm3
Hb>=10 g/dl
Platelet>=100,000/mm3
Total bilirubin<=1.5 mg/dl (<=25.65 umol/L)
AST/ALT<=2 times upper limit of normal
Serum creatinine<=1.5 mg/dl (<=132.6 umol/L)
8. Written informed consent
9. Diagnostic images (CT of the abdomen and pelvis is needed, MRI of the pelvis is recommended but not mandatory) before starting EBRT.
10. No PALN metastasis on CT. (> 1 cm in minimum diameter)
Key exclusion criteria 1. Severe concomitant illness
2. History of other malignancies within the past 5 years except basal cell carcinoma or squamous cell carcinoma in-situ of the skin
3. Tumor with infiltration of lower 1/3 of the vagina
4. Patients who are pregnant or lactating
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Kato
Organization Saitama Medical University, International Medical Cente
Division name Department of Radiation Oncology,
Zip code
Address 1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL 042-984-4111
Email s_kato@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Okonogi
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3306
Homepage URL
Email okonogi.noriyuki@qst.go.jp

Sponsor
Institute Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Forum for Nuclear Cooperation in Asia
International Medical Center Saitama Medical University, Saitama, Japan
Gunma University Hospital, Gunma, Japan
Jichi Medical University Hospital, Tochigi, Japan
Tokyo Womens Medical University Hospital, Tokyo, Japan
Delta Limited Hospital, Dhaka, Bangladesh
United Hospital Limited, Dhaka, Bangladesh
The First Affiliated Hospital of Soochow University, Soochow, China
The Affiliated Changzhou Tumor Hospital of Soochow University, Changzhou, China
Cipto Mangunkusumo General Hospital, Jakarta, Indonesia
Dr. Sotomo General Hospital, Surabaya, Indonesia
Kazakh Scientific-Research Institute of Oncology and Radiology, Almaty, Kazakhstan
Semey Oncology Center, Semey, Kazakhstan
Korea Institute of Radiological and Medical Sciences, Seoul, Korea
Sarawak General Hospital, Kuching, Malaysia
National Cancer Institute, Putrajaya, Putrajaya, Malaysia
National Cancer Center of Mongolia, Ulaanbaatar, Mongolia
Jose R. Reyes Memorial Medical Center, Manila, the Philippines
St. Luke's Medical Center, Manila, the Philippines
Siriraj Hospital, Mahidol University, Bangkok, Thailand
National Cancer Hospital, Hanoi, Vietnam
Ho Chi Minh City Oncology Hospital, Vietnam, Vietnam
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Previously, the Forum for Nuclear Cooperation in Asia (FNCA) cooperative study group has reported the feasibility of cisplatin-based concurrent chemoradiotherapy using conventional brachytherapy. The purpose of this study is to evaluate the efficacy and early and late toxicities of concurrent chemoradiotherapy using IGBT in patients with advanced cervical cancer in FNCA cooperative countries.

To determine the safety and efficacy of 3D-image guided radiation therapy (3D-IGBT) for patients with locally advanced cervical cancer in FNCA countries.
Primary endpoint: 2-year overall survival rate
Secondary endpoints: 2-year local control rate, acute and late toxicities

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031617

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.