UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019798 |
|---|---|
| Receipt number | R000022878 |
| Scientific Title | A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer |
| Date of disclosure of the study information | 2015/11/17 |
| Last modified on | 2018/12/17 17:41:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer
Acronym
A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer
Scientific Title
A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer
Scientific Title:Acronym
A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer
Region
| Japan |
Condition
Condition
metastatic penile cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical trial of TIP (Paclitaxel, Ifosfamide, Cisplatin) chemotherapy for the penile cancer patients with lymph node metastasis (Tx, N2~3, M0) as a neo-adjuvant chemotherapy or distant metastasis as a first line chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate (complete remission + partial response).
Contrast enhanced computed tomography imaging is performed after the second cycle of chemotherapy and at the completion of chemotherapy. Tumor responses are assessed by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Key secondary outcomes
1.Adverse events are assessed according the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
2.Survival analysis
Median survival time, progression-free time, progression-free survival, cancer specific survival, overall survival
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
| Medicine |
Interventions/Control_1
The treatment regimen consisted of four cycles of 3 weeks duration each, in which patients received 175 mg/m2 paclitaxel intravenously (IV) over 180 minutes day 1; 1.2 g/m2 ifosfamide IV over 120 minutes days 1, 2, and 3; and 25 mg/m2 cisplatin IV over 120 minutes days 1, 2, and 3.
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
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
1. Patients with penile tumor, which has been confirmed to be pathologically squamous cell carcinoma by biopsy of primary lesion.
2. Patients with lymph node metastasis (Tx, N2~3, M0) or distant metastasis in the imaging.
3. Patients with at least one measurable lesion.
4.Patients with ECOG performance status 0-2.
5. Patients who may survive more than three months from the registration date.
6. Patients with major organ function is maintained.
WBC: >= 3,000/mm3
PLT: >= 100,000/mm3
AST(GOT) and ALT(GPT): Less than twice the upper limit of the facility reference value
Total bilirubin: < 2.0mg/dL
conjugated bilirubin: < 1.5mg/dL
estimated glomerular filtration rate (eGFR): >=40mL/min
7. Patients who have the consent in writing for the chemotherapy with the off-label use of the anti-cancer agent.
Key exclusion criteria
1. Patients with pulmonary fibrosis or interstitial pneumonia, who diagnosed by chest X-ray and clinical symptoms.
2.Patients with NYHA Class III or IV heart failure and/or patients who have a history of myocardial infarction within 6 months.
3. Patients with severe infection.
4.Patients with severe comorbidity (include uncontrolled diabetes mellitus in spite of insulin therapy).
5. Patients with severe drug allergy.
6.Patients with multiple active primary cancers.
7.Patients who wish to partner pregnancy in course of chemotherapy or within 6 months from the final chemotherapy.
8.Patients who are not suitable for chemotherapy with any reason are excluded by physician's judgment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yamashita |
Organization
Tohoku university hospital
Division name
Department of Urology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi.
TEL
022-717-7278
yamashita@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Yamashita |
Organization
Tohoku university hospital
Division name
Department of Urology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi.
TEL
022-717-7278
Homepage URL
yamashita@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
None
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
