UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013340 |
|---|---|
| Receipt number | R000015569 |
| Scientific Title | Prospective interventional study on safety of carbon ion radiotherapy and image-guided brachytherapy for locally advanced uterine cervical cancer (GUNMA1202) |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2021/06/08 14:39:57 |
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Basic information
Public title
Prospective interventional study on safety of carbon ion radiotherapy and image-guided brachytherapy for locally advanced uterine cervical cancer (GUNMA1202)
Acronym
Prospective interventional study on safety of carbon ion radiotherapy and brachytherapy for uterine cervical cancer
Scientific Title
Prospective interventional study on safety of carbon ion radiotherapy and image-guided brachytherapy for locally advanced uterine cervical cancer (GUNMA1202)
Scientific Title:Acronym
Prospective interventional study on safety of carbon ion radiotherapy and brachytherapy for uterine cervical cancer
Region
| Japan |
Condition
Condition
Locally advanced uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of the concurrent therapy of carbon ion radiotherapy and image-guided brachytherapy for locally advanced uterince cervical cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Incidence of dose-limiting toxicity.
2) Incidence rate of acute adverse effects (within 90 days after the start of treatment).
Key secondary outcomes
1) Primary response in pelvis.
2) Incidence rate of late adverse effect (after 90 days from the start of treatment).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Carbon ion radiotherapy
Image-guided brachytherapy
Chemotherapy (Cisplatin)
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) FIGO Stage II (larger than or equal to 4 cm), III, or IV.
3) No para-aortic lymph node with the smaller diameter equal to or larger than 1 cm is observed in CT within 4 weeks before registration.
4) Measurable tumors on CT or MRI.
5) Age >=20 <=75.
6) Performance status 0-2.
7) No prior history of surgery or chemotherapy for uterine cervical cancer.
8) No abnormality in major organ functions.
9) Expected life expectancy of more than 6 months.
10) Informed consent is obtained.
Key exclusion criteria
1) Tumor invasion to gastro-intestinal tract.
2) Past history of chemotherapy.
3) Past history of radiotherapy in pelvis.
4) Uncontrolled infection in pelvis.
5) Severe concomitant diseases.
6) Active concurrent cancers.
7) (Possibly) pregnant patients.
8) Other medically or psychologically unsuitable circumstances are present.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Research Center
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8378
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohno |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Research Center
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 03 | Month | 05 | 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
| 2013 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 05 | 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=R000015569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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