UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018517
Receipt number R000021355
Scientific Title Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Date of disclosure of the study information 2015/08/05
Last modified on 2016/09/17 11:38:00

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Basic information

Public title

Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials

Acronym

Cross over trial of GD and GP therapy in metastatic urothelial carcinoma

Scientific Title

Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials

Scientific Title:Acronym

Cross over trial of GD and GP therapy in metastatic urothelial carcinoma

Region

Japan


Condition

Condition

metastatic urothelial carcinoma patients after the failure in the cisplatin-based first line systemic chemotherapy

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Urothelial carcinoma (UC) is considered to be a chemosensitive malignancy. Cisplatin-based systemic chemotherapy is regarded as the gold standard regimens for treating patients with advanced or metastatic UC. For more than a decade, the combination regimens of methotrexate, vinblastine, doxorubicin, cisplatin (M-VAC) and methotrexate, epirubicin, cisplatin (MEC) chemotherapy have been held as the standard in treating advanced or metastatic UC patients. Objective response rates of these regimens were approximately 50% in randomized trials. Recently, combined chemotherapy with gemcitabine and cisplatin (GC) has become another standard treatment for advanced UC. However, long-term follow-up results have revealed that overall survival or progression free survival was never satisfactory, particularly with metastatic UC. There is no standard second-line treatment in patients with metastatic UC after failure of platinum-based chemotherapy. Therefore, in the present study, we evaluated the feasibility, toxicity, and efficacy of sequential therapy using Gemcitabine and docetaxel combination regimen, and Gemcitabine and paclitaxel combination regimen in patients with metastatic UC who were refractory to cisplatin-based first-line chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

adverse event
progression free survival
objective response rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

GD therapy: gemcitabine 800 mg/m2 administered by a 30 min intravenous infusion on days 1, and 8 and docetaxel 40 mg/m2 also by intravenous infusion on days 1 and 8

Interventions/Control_2

gemcitabine 1000 mg/m2 administered by a 30 min intravenous infusion on days 1, 8, and 15, and paclitaxel 200 mg/m2 also by intravenous infusion on days 1

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Eligible patients had histologically proven metastatic UC of the urinary bladder or upper urinary tract. All of the patients had received surgical treatment or been biopsied for the primary lesions. Also, all had one previous chemotherapy treatment that consisted of M-VAC, MEC, or GC. Previous chemotherapy was completed at least 4 weeks before enrollment. Patients were required to have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 2 or lower as per the World Health Organization criteria; adequate bone marrow reserve (white blood cell (WBC) count higher than 3,500, platelet count higher than 100,000, and hemoglobin higher than 10 g/dL) was required of all patients. Other requirements were: adequate hepatic function (serum bilirubin 1.5 mg/dl, or less), adequate renal function (serum creatinine 1.5 mg/dl, or measured creatinine clearance of at least 60 ml/min), and an estimated life expectancy of at least 12 weeks. Patients with non-malignant systemic disease that precluded them from receiving therapy, including active infection, any clinically significant cardiac arrhythmia, and/or congestive heart failure, were not eligible. Written informed consent was obtained from all of the patients before this clinical trial.

Key exclusion criteria

exclusion criteria patients were below: the patients who had allergy to gemcitabine, and , or taxane derivatives, or patients suspected interstitial lung disease by X ray, or patients who had past history of radiation theapy in chest, or patients suspected infection diseases, or patients who had the possibility of pregnancy, or patients who had uncontrolled cancer diffferent from urothelial cancer.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taku Naiki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code


Address

Kawasumi 1, Mizuho-cho, Mizuho-ku 467-8601, Nagoya, Japan.

TEL

052-853-8266

Email

naiki@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taku Naiki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code


Address

Kawasumi 1, Mizuho-cho, Mizuho-ku 467-8601, Nagoya, Japan.

TEL

052-853-8266

Homepage URL


Email

naiki@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

名古屋市立大学病院


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 05 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

2015 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 05 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 08 Month 01 Day

Last modified on

2016 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name