UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002697 |
|---|---|
| Receipt number | 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 15:39:56 |
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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
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
mailzhuyao@163.com
Sponsor or person
Institute
Fudan University Shanghai Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003289
