UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037859 |
|---|---|
| Receipt number | R000043116 |
| Scientific Title | The clinical study of intra-arterial chemotherapy using several anticancer agents for oral cancer |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2021/03/08 13:38:53 |
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Basic information
Public title
The clinical study of intra-arterial chemotherapy using several anticancer agents for oral cancer
Acronym
The clinical study of intra-arterial chemotherapy using several anticancer agents for oral cancer
Scientific Title
The clinical study of intra-arterial chemotherapy using several anticancer agents for oral cancer
Scientific Title:Acronym
The clinical study of intra-arterial chemotherapy using several anticancer agents for oral cancer
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Since 2003, we have performed intra-arterial chemotherapy with docetaxel (DOC), cisplatin (CDDP), and peplomycin (PEP) combined with intravenous chemotherapy using 5-fluorouracil (5-FU) (IADCPIVF) in the treatment of oral cancer. In IADCPIVF, the total doses of each anticancer drug, which were less than half of total doses in these intravenous administration regimens (DOC, 30-40 mg/body; CDDP, 30-40 mg/body; PEP, 10 mg/body; 5FU, 2500mg/body) were administered continuously for 10 days.
IADCPIVF as a preoperative chemotherapy was administered to 141 patients from 2003 to 2015, with a primary tumor response rate of 98%. Additionally, there were no serious adverse events associated with IADCPIVF, which was successfully completed in elderly patients aged more than 80 years. However, intensive mucositis at the treatment site was found, and management of the indwelling catheter to avoid the accident was required for 10 days. In 2012, the IADCPIVF period was shortened to 5 days, with no changes in the total dose of these drugs. The second course of treatment was administered 4 weeks after the first course when necessary.
In the current study, we investigate retrospectively whether the efficacy and safety of IADCPIVF vary by duration of administration, comparing patients treated between 2003 and 2012, and those treated after 2012.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
1, Age
2, Site
3, TNM classification
4, Catheter placement
5, Total doses of anticancer drugs
6, Frequency of administration
7, Clinical tumor response
8, Pathological tumor response
9, Recurrence
10, Adverse events
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients with oral cancer have no severe disorders of vital organs such as the bone marrow, liver, or kidney.
Key exclusion criteria
Patients with a performance status of 4 (Eastern Cooperative Oncology Group) are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University, School of Medicine
Division name
Dentistry and Oral Surgery
Zip code
9601295
Address
1 Hikariga-oka, Fukushima City, Japan
TEL
+81245471111
hi61hasegawa@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University, School of Medicine
Division name
Dentistry and Oral Surgery
Zip code
9601295
Address
1 Hikariga-oka, Fukushima City, Japan
TEL
+81245471111
Homepage URL
oralsurg@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukushima Medical University Clinical Research Center
Address
1 Hikariga-oka, Fukushima City, Japan
Tel
81245471825
rs@fmu.ac.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
| 2019 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Eligible patients have undergone intra-arterial chemotherapy with docetaxel (DOC), cisplatin (CDDP), and peplomycin (PEP) combined with intravenous chemotherapy using 5-fluorouracil (5-FU) for oral cancer since 2003.
We investigate retrospectively whether the efficacy and safety of this chemotherapy vary by duration of administration, comparing patients treated between 2003 and 2012, and those treated after 2012.
Management information
Registered date
| 2019 | Year | 08 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043116
