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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000039045 |
Receipt No. | R000044524 |
Scientific Title | Phase 1 multi-center study of safety and feasibility of chemoradiotherapy using oxydol for cervical cancer |
Date of disclosure of the study information | 2020/01/06 |
Last modified on | 2020/01/03 |
Basic information | ||
Public title | Phase 1 multi-center study of safety and feasibility of chemoradiotherapy using oxydol for cervical cancer
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Acronym | Pilot study of chemoradiotherapy using oxydol for cervical cancer | |
Scientific Title | Phase 1 multi-center study of safety and feasibility of chemoradiotherapy using oxydol for cervical cancer | |
Scientific Title:Acronym | Pilot study of chemoradiotherapy using oxydol for cervical cancer | |
Region |
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Condition | ||
Condition | cervical cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Analyze the feasibility and safety using hydrogen peroxide as a substitute of brachytherapy for cervical cancer
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Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | 1 month after treatment completion, 1 year, 2 years overall survival, disease-free survival and progression-free survival |
Key secondary outcomes | Type, severity, and ratio of adverse events that occurred up to the date of follow-up observation |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Hydrogen peroxide was to be used twice a week (Monday and Thursday/Tuesday and Friday) in combination with CCRT. We inserted 3% hydrogen peroxide solution-soaked gauze into vagina firmly contact to the lesion immediately before RT and removed it right after RT.This procedure was done by the attending gynecologist. | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | we recruited patients who have cervical caner needed radio-sensitization treatment because of unfeasibility to the standard therapy. Our selection criteria are as follow: cervical cancer patient; radical CCRT purpose; impossible or refusal of brachytherapy; 20 years or older ; without hematogenous metastasis ; having a ECOG Performance Status up to 2, and no pathological limitation, without prior treatment. | |||
Key exclusion criteria | less than 20 years old
having distant metastasis |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Juntendo University Urayasu Hospital | ||||||
Division name | Department of Radiation Oncology | ||||||
Zip code | 279-0021 | ||||||
Address | 2-1-1 Tomioka, Urayasu-shi, Chiba | ||||||
TEL | 047-353-3111 | ||||||
anyusaike@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Juntendo University Urayasu Hospital | ||||||
Division name | Department of Radiation Oncology | ||||||
Zip code | 279-0021 | ||||||
Address | 2-1-1 Tomioka, Urayasu-shi, Chiba | ||||||
TEL | 047-353-3111 | ||||||
Homepage URL | |||||||
anyusaike@yahoo.co.jp |
Sponsor | |
Institute | Juntendo University Urayasu Hospital |
Institute | |
Department |
Funding Source | |
Organization | Juntendo University Urayasu Hospital |
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 | Juntendo University Urayasu Hospital |
Address | 2-1-1 Tomioka, Urayasu-shi, Chiba |
Tel | 047-353-3111 |
anyusaike@yahoo.co.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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 20 |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044524 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |