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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002697
Receipt No. R000003289
Scientific Title Phase II trial of docetaxel (T), cisplatin (P) and fluorouracil (5-FU) in the treatment of metastatic penile cancer
Date of disclosure of the study information 2009/11/01
Last modified on 2015/01/02

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Basic information
Public title Phase II trial of docetaxel (T), cisplatin (P) and fluorouracil (5-FU) in the treatment of metastatic penile cancer
Acronym TPF in penile cancer
Scientific Title Phase II trial of docetaxel (T), cisplatin (P) and fluorouracil (5-FU) in the treatment of metastatic penile cancer
Scientific Title:Acronym TPF in penile cancer
Region
Asia(except Japan)

Condition
Condition patients with metastatic penile cancer
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of chemotherapy with docetaxel, cisplatin and fluorouracil in penile cancer in a phase II trial
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate,
Toxicity
Key secondary outcomes Progression free survival,
Quality of life

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 docetaxel, cisplatin and fluorouracil
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
18 years-old <
Age-upper limit
75 years-old >
Gender Male
Key inclusion criteria 1) Pathologically confirmed penile squamous cell carcinoma
2) M1 disease
3) At least one measurable tumor lesion
4) ECOG PS 0-1
5) Age 18-75
6) Normal organ function
7) Written informed consent
Key exclusion criteria 1) Usage of experimental drugs
2) History of serious drug allergy or hypersensitivity with cisplatin or paclitaxel
3) Peripheral neuropathy
4) Ototoxicity
5) Uncontrolled infection
6) Double cancer
7) Coexisting severe medical conditions
8) Mental disease
9) Judged as inappropriate to participate this trial by investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ding-Wei Ye
Organization Fudan University Shanghai Cancer Center
Division name Department of Urology
Zip code
Address No. 270 Dong'an Road
TEL 86-21-64175590
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yao Zhu
Organization Fudan University Shanghai Cancer Center
Division name Department of Urology
Zip code
Address No. 270 Dong'an Road
TEL 86-21-64175590
Homepage URL
Email mailzhuyao@163.com

Sponsor
Institute Fudan University Shanghai Cancer Center
Institute
Department

Funding Source
Organization Fudan University Shanghai Cancer Center
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
Address
Tel
Email

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 Fudan University Shanghai Cancer Center

Other administrative information
Date of disclosure of the study information
2009 Year 11 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 01 Day
Last modified on
2015 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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