UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056983 |
|---|---|
| Receipt number | R000061902 |
| Scientific Title | Radiosensitization treatment using hydrogen peroxide for inoperable rectal cancer |
| Date of disclosure of the study information | 2025/02/08 |
| Last modified on | 2025/02/08 18:41:48 |
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Basic information
Public title
Radiosensitization treatment using hydrogen peroxide for inoperable rectal cancer
Acronym
Radiosensitization treatment using hydrogen peroxide for inoperable rectal cancer
Scientific Title
Radiosensitization treatment using hydrogen peroxide for inoperable rectal cancer
Scientific Title:Acronym
RADIOSENSITIZATION TREATMENT FOR RECTAL CANCER
Region
| Japan |
Condition
Condition
inoperable rectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluated the feasibility and safety of radiosensitization using hydrogen peroxide combined with radiation therapy in patients with unresectable rectal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of acute and late adverse events 1 and 6 months after completion of radiotherapy.
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
Radiosensitization was performed twice weekly in combination with RT. A gauze soaked in 3% hydrogen peroxide solution was inserted into the anus, ensuring firm contact with the lesion.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable rectal cancer, who refused to undergo resection for rectal cancer, or who had recurrent rectal cancer were included in this study. Tumors must be histologically proven to be locally advanced rectal cancers, with a performance status of 0 or 1
Key exclusion criteria
N/A
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Anneyuko |
| Middle name | I |
| Last name | Saito |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
279-0021
Address
2-1-1 omioka Urayasushi Chibaken
TEL
047-353-3111
anne@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Anneyuko |
| Middle name | I |
| Last name | Saito |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
279-0021
Address
2-1-1 omioka Urayasushi Chibaken
TEL
047-353-3111
Homepage URL
anne@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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 Faculty of Medicine
Address
2-1-1 Bunkyoku Hongo Tokyo
Tel
03-3813-3111
https://jcrtc.juntendo.ac.jp/contact-researcher/
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
| 2025 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39091416/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39091416/
Number of participants that the trial has enrolled
13
Results
Treatment was well tolerated, with no acute grade 3 or worse events noted. No notable late adverse events, beyond 6 months, were observed at the end of the analysis. All patients experienced pain relief, hemostatic effects and tumor shrinkage. Therefore, the use of a hydrogen peroxide solution-soaked gauze in the rectum may be a promising option for patients with inoperable rectal tumors.
Results date posted
| 2025 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirteen patients met the inclusion criteria and agreed to participate. Out of the patients, 7 underwent chemoradiotherapy with tegafur gimeracil oteracil potassium and all the other underwent radiotherapy alone.
Participant flow
Radiosensitization treatment was performed twice a week to avoid severe adverse events. hydrogen peroxide was used twice a week in combination with RT. Here immediately before RT, gauze soaked in 3% hydrogen peroxide solution was inserted into the anus, ensuring firm contact with the lesion. After that radiotherapy was performed.
Adverse events
Treatment was well tolerated, with no acute grade 3 or worse events noted, and no patient developed rectal fistula, necrosis, obstruction, perforation, stenosis, ulcer or retroperitoneal hemorrhage. No notable late adverse events, beyond 6 months, were observed at the end of the analysis.
Outcome measures
Adverse effect and treatment effect
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061902
