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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000017656 |
Receipt No. | R000020454 |
Scientific Title | A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer |
Date of disclosure of the study information | 2015/05/25 |
Last modified on | 2018/03/31 |
Basic information | ||
Public title | A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer | |
Acronym | A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer | |
Scientific Title | A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer | |
Scientific Title:Acronym | A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer | |
Region |
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Condition | ||
Condition | Head and neck squamous cell carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | In this clinical trial, the maximum tolerrated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of intra-arterial infusion chemotherapy with cisplatin and radiotherapy for head and neck cancer
, and the recommended dose (RD) for the prospective study will be determined. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | maximum tolerrated dose, recommended dose |
Key secondary outcomes | response rate, toxicity, overall survival, local control time, progression free time |
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 |
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Interventions/Control_1 | Combined therapy of intra-arterial infusion chemotherapy with cisplatin and radiotherapy | |
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 | Male and Female | |||
Key inclusion criteria | 1)Head and neck cancer
2)Stage 3, 4A, or 4B 3)Without previous irradiation for head and neck 4)Without previous chemotherapy with cisplatin 5)Squamous cell carcinoma 6)>=20, <=80 7)Performance Status(ECOG) 0-2 8)WBC >3000/mm3, Neutrophil >1500/mm3 9)Hb >9g/dL 10)PLT >=100,000/mm3 11)AST, ALT <3 times the upper limit of normal 12)total bilirubin <2mg/dL 13)Creatinine clearance >50mL/min 14)Provided written informed consent |
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Key exclusion criteria | 1)Prior history of radiotherapy for head and neck
2)History of serious drug allegies 3)With severe complications (hepatic disorder, renal disorder,or heart disease, bowel obstruction, peptic ulcer, severe diabetes) 4)with history of severe mental disorder 5)pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 6)Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Mie University Graduate School of Medicine | ||||||
Division name | Department of Radiation Oncology | ||||||
Zip code | |||||||
Address | 2-174, Edobashi, Tsu, Mie | ||||||
TEL | 059-231-5029 | ||||||
nomoto-y@clin.medic.mie-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Mie University Hospital | ||||||
Division name | Department of Radiation Oncology | ||||||
Zip code | |||||||
Address | 2-174, Edobashi, Tsu, Mie | ||||||
TEL | 059-231-5029 | ||||||
Homepage URL | |||||||
y-toyomasu@clin.medic.mie-u.ac.jp |
Sponsor | |
Institute | Department of Radiology Mie University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Donation for research |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
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=R000020454 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |