UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016140 |
|---|---|
| Receipt number | R000018670 |
| Scientific Title | A prospective multicenter study on 3D image-guided brachytherapy for locally advanced cervical cancer |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2015/01/06 21:24:21 |
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Basic information
Public title
A prospective multicenter study on 3D image-guided brachytherapy for locally advanced cervical cancer
Acronym
A prospective multicenter study on 3D image-guided brachytherapy for locally advanced cervical cancer
Scientific Title
A prospective multicenter study on 3D image-guided brachytherapy for locally advanced cervical cancer
Scientific Title:Acronym
A prospective multicenter study on 3D image-guided brachytherapy for locally advanced cervical cancer
Region
| Japan |
Condition
Condition
Locally advanced cervical cancer (FIGO IIa2,IIb,III,IVa)
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of the concurrent therapy of Image-guided brachytherapy combined with conformal external beam radiotherapy and chemotherapy for locally advanced cervical cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic disease progression-free rate
Key secondary outcomes
Overall survival rate ,Local control rate, Incidence rate of acute adverse effects , Incidence rate of late adverse effect
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 | Device,equipment | Maneuver |
Interventions/Control_1
External beam radiotherapy: 50 Gy / 25 fractions
Image-guided brachytherapy: 18-24 Gy / 3-4 fractions
Chemotherapy: weekly cisplatin 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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically diagnosed adenocarcinoma, adeno-squamous cell carcinoma, or squamous cell carcinoma of uterine cervix.
2. International Federation of Gynecology and Obstetrics (FIGO) Stage IIa2 , IIb , 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 by MRI.
5. Tumor size is >= 4 cm in diameter
6. Age between 20 and 75 years
7. Performance status 0 - 2
8. Patients with no histories of prior chemotherapy or pelvic surgery for cervical cancer
9. Normal organ function
(WBC >= 3000/mm3,Hb >= 9.5g/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
10. Informed consent is obtained
Key exclusion criteria
1. Tumor invasion to gastro-intestinal tract.
2. Uncontrolled infection in pelvis
3. Rectal invasion History of pelvic radiotherapy
4. Severe complicating illness
5. Active double cancer
6. Possibility of pregnancy or lactation period
7. medical, psychological or others reason that primary doctor think ineligible
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Department of Radiation Oncology
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
(027)220-8383
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohno |
Organization
Gunma University
Division name
Department of Radiation Oncology
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
(027)220-8383
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 06 | Day |
Last modified on
| 2015 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018670
