UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001994
Receipt number R000002427
Scientific Title Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma
Date of disclosure of the study information 2009/05/21
Last modified on 2018/11/01 19:19:34

* 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

Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma

Acronym

Comparative Study of Sequential Therapy with Interferon and Molecular-Targeted Drug for Renal Cell Carcinoma

Scientific Title

Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma

Scientific Title:Acronym

Comparative Study of Sequential Therapy with Interferon and Molecular-Targeted Drug for Renal Cell Carcinoma

Region

Japan


Condition

Condition

Advanced Renal Cell Carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety between two sequential therapies, sunitinib followed by sorafenib versus interferon followed by sorafenib, in advanced renal cell carcinoma patients without prior systemic treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression-free survival

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sumiferon 6 million units will be subcutaneously administered three times a week, and treatment will be continued. Judgment for treatment efficacy will be made at least after 12-week treatment. At the time when PD is shown by judgment for treatment efficacy, subjects will be transferred to the secondary treatment. As the secondary treatment, Nexavar 400 mg will be orally administered twice daily every day until PD is shown.

Interventions/Control_2

SUTENT 50 mg will be orally administered once daily for 4 weeks and then treatment will be withdrawn for 2 weeks. A total of 6 weeks is 1 course, and subjects will be transferred to the secondary treatment at the time when PD is shown. As the secondary treatment, Nexavar 400 mg will be orally administered twice daily every day until PD is shown.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients histopathologically diagnosed as renal cell carcinoma with the presence of clear cell carcinoma
2. Patients with a metastatic focus limited to the lung and/or mediastinal lymph node
3. Patients with the MSKCC risk of favorable or intermediate
4. Patients with a measurable lesion in accordance with RECIST
5. Patients with a history of nephrectomy
6. Patients for whom all of acute toxicities caused by medications, radiotherapy, or surgical procedure in the past have disappeared down to Grade 1 or less of CTCAE ver. 3.0
7. Patients aged at least 20 years
8. Patients whose performance status (ECOG classification) is 0 to 1
9. Patients for whom survival for more than 3 months can be expected
10. Patients for whom functions of organs are maintained
11. Women after menopause or who agree to contraception or is surgically sterile. For men, those who agree to contraception or had an sterilization procedure
12. Patients from whom written consent is obtained

Key exclusion criteria

1.Patients who have had systemic treatment for renal cancer
2.Patients for whom the period after a surgery or the end of radiotherapy is less than 4 weeks at the start of protocol treatment
3.Patients suffering double carcinoma within 5 years. However, the following patients who received appropriate treatment are acceptable as the subjects.
a. Basal cell carcinoma of the skin or squamous cell cancer
b. Cervical cancer, stomach cancer, or colon cancer (in situ)
4.Patients diagnosed as brain metastasis, spinal cord compression, or meningitis carcinomatosa
5.Patients showing either of the following within 12 months before the start of protocol treatment:
Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral bypass graft, symptomatic congestive heart failure, cerebrovascular attack or transient ischemic attack, or pulmonary embolism
6.Patients with arrhythmia or atrial fibrillation (any grade) by CTCAE Ver. 3.0, or QTc interval prolongation at >450 msec in men and >470 msec in women
7.Patients with uncontrollable hypertension (>150/100 mmHg in spite of the most proper medication)
8.Patients administered warfarin continuously (oral administration of a low dose of warfarin up to 2 mg/day is acceptable)
9.Patients for whom human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases or hepatitis B or C virus are confirmed

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotsugu Uemura

Organization

Kinki University School of Medicine

Division name

Department of Urology

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Nozawa

Organization

Osaka Urological Oncology Research Group

Division name

Executive Office

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka Urological Oncology Research Group

Institute

Department

Personal name



Funding Source

Organization

Osaka Kidney Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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 05 Month 21 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 01 Month 30 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2013 Year 08 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 05 Month 21 Day

Last modified on

2018 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002427


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name