UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027578 |
|---|---|
| Receipt number | 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 | 2024/09/08 20:16:24 |
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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 | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medical University, International Medical Cente
Division name
Department of Radiation Oncology,
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
s_kato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
Homepage URL
okonogi.noriyuki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
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
Certificated Review Board, National Institutes for Quantum and Radiological Sciences and Technology
Address
4-9-1 Anagawa, Inage, Chiba
Tel
043-206-4706
helsinki@qst.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
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
108
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
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
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031617
