UMIN-CTR Clinical Trial

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
Email	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
Email	oralsurg@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043116