UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028672 |
|---|---|
| Receipt number | 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 | 2021/06/08 20:36:37 |
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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 | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medical University, International Medical Center
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
Hospital of the National Institute of Radiological Sciences
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
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
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
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel
043-206-3306
wakatsuki.masaru@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 | 08 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0360301619307370?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0360301619307370?via%3Dihub
Number of participants that the trial has enrolled
106
Results
A total of 106 patients were enrolled. Of these, 9 had major protocol violations and 2 did not receive treatment because of worsened general condition. Thus, 95 patients were evaluable. The 2-year local control, progression-free survival, and overall survival rate for all patients were 96%, 78%, and 90%, respectively.
Results date posted
| 2021 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between October 2007 and May 2016, 106 patients with untreated squamous cell carcinoma of the cervix were enrolled in the present study.
Participant flow
Observational study
Adverse events
Acute grade 3 leukopenia was observed in 20 of the patients (21%), and late grade 3 gastrointestinal toxicity was observed in 3%.
Outcome measures
The 2-year local control, progression-free survival, and overall survival rate for all patients were 96%, 78%, and 90%, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
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
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032826
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| Registered date | File name |
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