UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the efficacy and safety of chemotherapy with paclitaxel, ifosfamide, cisplatin for metastatic penile cancer
Title of the study (Brief title)	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	Shinichi Yamashita
Organization	Tohoku university hospital
Division name	Department of Urology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi.
TEL	022-717-7278
Email	yamashita@uro.med.tohoku.ac.jp

Public contact
Name of contact person	Shinichi Yamashita
Organization	Tohoku university hospital
Division name	Department of Urology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi.
TEL	022-717-7278
Homepage URL
Email	yamashita@uro.med.tohoku.ac.jp

Sponsor
Institute	Tohoku university hospital, Department of Urology
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022878