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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028672
Receipt No. R000032826
Scientific Title CCRT with Prophylactic PALN regional RT for locally advanced cervical cancer (Cervix-IV)
Date of disclosure of the study information 2017/08/16
Last modified on 2018/08/16

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Basic information
Public title CCRT with Prophylactic PALN regional RT for locally advanced cervical cancer (Cervix-IV)
Acronym FNCA Cervix-IV
Scientific Title CCRT with Prophylactic PALN regional RT for locally advanced cervical cancer (Cervix-IV)
Scientific Title:Acronym FNCA Cervix-IV
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 assess the clinical outcomes of CCRT with prophylactic PALN regional RT 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 progression-free survival rate
Key secondary outcomes 2-year overall survival 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
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 Center
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
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 08 Month 16 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 No longer recruiting
Date of protocol fixation
2007 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information To evaluate the efficacy of the combination of CCRT using CDDP to the pelvis and prophylactic PALN RT for locally advanced cervical cancer patients in FNCA countries. This is an observational study.

Management information
Registered date
2017 Year 08 Month 15 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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