UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002450
Receipt number R000002640
Scientific Title Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study
Date of disclosure of the study information 2009/10/01
Last modified on 2012/09/28 23:40:17

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Basic information

Public title

Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study

Acronym

Study of GP versus G regimen in patients with cisplatin-refractory urothelial cancer

Scientific Title

Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study

Scientific Title:Acronym

Study of GP versus G regimen in patients with cisplatin-refractory urothelial cancer

Region

Japan


Condition

Condition

Urothelial cancer

Classification by specialty

Hematology and clinical oncology Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the responsive rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

gemcitabine/paclitaxel combination therapy

Interventions/Control_2

gemcitabine monotherapy

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Urothelial cancer was (must be) confirmed by histological or cytological methods. 2. Locally advanced (T4b, N1-3) or metastatic urothelial cancer who are not eligible for radical surgery 3. Patients had measurable diseases. 4. Regardless of the objectives, CDDP-resistant urothelial cancer. 5. PS 0-2 6. Prior chemotherapy with gemcitabine or paclitaxel was not allowed. 7. major organ function were maintained

Key exclusion criteria

1. prior chemotherapy with gemcitabine or paclitaxel
2. patients with interstitial pneumoniae and pulmonary fibrosis
3. patients with body fluid with the necessity of drainage or severe edema
4. patients with brain metastasis with the necessity of treatment
5. active double cancer
6. severe or uncontrollable complications
7. patients with allergy to polyoxyethylene castor oil-contain drug (e.g., CDDP) or sclerosing castor oil-contain drug (e.g., injectable vitamins)
8. Not eligible for patients during Pregnancy or Lactation, and with the hope of pregnancy
9. Prior therapy is allowed if this is
completed more than 28 days before study entry.
10. Otherwise, patients are judged to be not eligible by the attending doctor.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeo Horie

Organization

Teikyo University, School of Medicine

Division name

Department of Urology

Zip code


Address

2-11-1, Kaga, Itabashi-ku

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Teikyo University, School of Medicine

Division name

Department of Urology

Zip code


Address


TEL


Homepage URL


Email

muto@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

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



Other administrative information

Date of disclosure of the study information

2009 Year 10 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

Terminated

Date of protocol fixation

2009 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2012 Year 06 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 09 Month 05 Day

Last modified on

2012 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002640


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name