UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002466 |
|---|---|
| Receipt number | R000003019 |
| Scientific Title | Multi-Center Phase II Clinical Trial on Efficacy and Safety of Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma |
| Date of disclosure of the study information | 2009/09/09 |
| Last modified on | 2014/04/08 10:42:14 |
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Basic information
Public title
Multi-Center Phase II Clinical Trial on Efficacy and Safety of
Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma
Acronym
Phase II of Interferon Alfa-n1 + Sorafenib in Renal Cell Carcinoma
Scientific Title
Multi-Center Phase II Clinical Trial on Efficacy and Safety of
Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma
Scientific Title:Acronym
Phase II of Interferon Alfa-n1 + Sorafenib in Renal Cell Carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the trial is to study the efficacy and safety of Interferon Alfa-n1 and sorafenib combination therapy in patients with renal cell carcinoma who have no history of cytokine therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate (CR+PR)
Key secondary outcomes
Disease Control Rate(CR+PR+SD),Progression Free Survival,Safety
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
Interferon Alfa-n1 monotherapy will be performed for 2 weeks. Patients will be checked for adverse event caused by Interferon Alfa-n1. Interferon Alfa-n1+ sorafenib combination therapy will be performed after it has been confirmed that there are no problems. Interferon Alfa-n1 will be given by subcutaneous or intramuscular injection 300MU once a day, 3 times a week. Sorafenib will be given by daily oral administration of 400 mg twice a day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: 20 <=
2) Patients with confirmed clear cell renal cell carcinoma
3) Patients who have already tried nephrectomy
4) patients with no previous history of chamotherapy,cytokine therapy,or molecularly targeted drug therapy(however,patients using IFN alfa as post-nephrectomy adjuvant therapy for primary tumors will be eligible if not used for 6 or more months)
5) Patients with ECOG PS 0 or 1
6) patients with at least 1 measurable lesion on CT, as defined by RECIST
7) Patients who are expected to survive at least 12 weeks
8) Patients who meet(1)through(9) of the following test within 7 days before the start of Interferon Alfa-n1 monotherapy
(1) hemoglobin >= 9.0 g/dL
(2) neutrophil count >= 1,500/microL
(3)
(4) PT or PT-INR and APTT <= 1.5 times the maximum of the normal range at the study site
(5) total bilirubin <= 1.5 times the maximum of the normal range at the study site
(6) ALT and AST <= 2.5 times the maximum of the normal range at the study site ( <= 5 times the maximum of the normal range at the study site in patients with hepatic metastasis)
(7) alkali phosphatase <= 4 times the maximum of the normal range at the study site
(8) serum creatinine <= 2.0 times the maximum of the normal range at the study site
(9) amylases and lipases <=2.0 times the maximum of the normal range at the study site
9) Patients who give written informed consent prior to the study
Key exclusion criteria
1) Congestive cardiac failure
2) Severe arrhythmias
3) Active or symptomatic angina pectoris or coronary artery disease
4) Poorly controlled hypertension
5) History of HIV infection, or active chronic hepatitis caused by type B or type C hepatitis virus
6) Active infection
7) Intracranial metastasis
8) Convulsive disorders requiring treatment with anticonvulsants
9) History of organ transplant
10) Poorly controlled depression
11) Autoimmune hepatitis
12) History of malignant tumors
13) Radiation therapy, except for palliative therapy, within 3 weeks prior to the start of treatment
14) Significantly invasive surgery within 4 weeks prior to the start of treatment
15) Use of G-CSF within 3 weeks prior to the start of treatment
16) Pts with a history of treatment using drugs targeting VEGF or VEGF receptor
17) Pts with a history of treatment using Raf kinase, MEK, farnesyl transferase inhibitors
18) Pts being treated with adrenocortical steroids
19) Pts being treated with Minor Bupleurum Formula
20) Pts who have or have had interstitial pulmonary disease
21) Pregnant or nursing patients
22) Pts who are unable to practice appropriate contraception throughout the study period
23) Pts who abuse drugs or who have health conditions, psychological states, or social circumstances which would interfere with participation in the study or assessment of results
24) Pts with diseases or disability potentially affecting drug assessment
25) Patients who have had, or are suspected of having, allergies to sorafenib, Interferon Alfa-n1, or other interferon formulations
26) Pts with a history of hypersensitivity to biological preparations such as vaccines
27) Patients for whom oral medication may be difficult to take
28) Patients who previously encountered difficulties in treatment with IFN alfa due to adverse events caused by IFN alfa, or patients in whom IFN alfa-induced adverse events persist to this day
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Eto |
Organization
Graduate School of Medical Science, Kumamoto University
Division name
Department of Urology
Zip code
Address
1-1-1, Honjo Kumamoto, 860-8556 Japan
TEL
096-373-5240
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Eto |
Organization
Graduate School of Medical Science, Kumamoto University
Division name
Department of Urology
Zip code
Address
1-1-1, Honjo Kumamoto, 860-8556 Japan
TEL
096-373-5240
Homepage URL
Sponsor or person
Institute
Japan RCC Trialist Collaborative Group (JRTCG)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
東京女子医科大学 (東京都)
神戸大学大学院医学研究科 (兵庫県)
九州大学大学院医学研究院 (福岡県)
自治医科大学 (栃木県)
大阪大学大学院医学研究科器官制御外科学 (大阪府)
鹿児島大学大学院医歯学総合研究科 (鹿児島県)
四国がんセンター (愛媛県)
広島大学大学院医歯薬学総合研究科 (広島県)
防衛医科大学校医学研究科 (埼玉医大)
横浜市立大学大学院医学研究科 (神奈川県)
名古屋大学大学院医学研究科 (愛知県)
日本医科大学 (東京都)
京都大学大学院医学研究科 (京都府)
奈良県立医科大学 (奈良県)
倉敷中央病院 (岡山県)
山形大学医学部 (山形県)
北海道大学大学院医学研究科 (北海道)
広島市立安佐市民病院 (広島県)
弘前大学大学院医学研究科 (青森県)
原三信病院 (福岡県)
慶應義塾大学 (東京都)
熊本大学大学院医学薬学研究部 (熊本県)
仙台社会保険病院 (宮城県)
浜松医科大学医学部 (静岡県)
徳島大学大学院 (徳島県)
札幌医科大学 (北海道)
獨協医科大学 (栃木県)
筑波大学大学院 (茨城県)
北海道がんセンター (北海道)
砂川市立病院 (北海道)
旭川医科大学 (北海道)
伊勢崎市民病院 （群馬県）
東京女子医科大学東医療センター（東京都）
東北大学大学院医学系研究科（宮城県）
宮崎大学（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 09 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 07 | Day |
Last modified on
| 2014 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003019
