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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00375674




Registration number
NCT00375674
Ethics application status
Date submitted
12/09/2006
Date registered
13/09/2006
Date last updated
21/09/2018

Titles & IDs
Public title
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Scientific title
Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc
Secondary ID [1] 0 0
2006-004024-37
Secondary ID [2] 0 0
A6181109
Universal Trial Number (UTN)
Trial acronym
S-TRAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sunitinib malate
Other interventions - Placebo

Experimental: A -

Placebo Comparator: B -


Treatment: Drugs: Sunitinib malate
sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.

Other interventions: Placebo
Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review
Timepoint [1] 0 0
Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.
Primary outcome [2] 0 0
DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]
Timepoint [2] 0 0
Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later
Secondary outcome [1] 0 0
Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)
Timepoint [1] 0 0
Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)
Secondary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Timepoint [2] 0 0
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
Secondary outcome [3] 0 0
Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)
Timepoint [3] 0 0
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
Secondary outcome [4] 0 0
Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores
Timepoint [4] 0 0
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary outcome [5] 0 0
PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison
Timepoint [5] 0 0
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary outcome [6] 0 0
PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison
Timepoint [6] 0 0
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary outcome [7] 0 0
PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population
Timepoint [7] 0 0
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary outcome [8] 0 0
PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means
Timepoint [8] 0 0
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary outcome [9] 0 0
Number of Participants With Tolerability Symptoms
Timepoint [9] 0 0
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later

Eligibility
Key inclusion criteria
- High risk renal cancer per modified UISS criteria

- Eastern Cooperative Oncology Group (ECOG) 0-2

- predominant clear cell histology

- No prior anti-cancer treatment

- Kidney tumor has been removed

- No evidence of macroscopic disease following surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
sarcoma or subjects with metastatic renal sites.

- Diagnosis of any second malignancy within the last 5 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that
has been adequately treated with no evidence of recurrent disease for 12 months

- known HIV or Hepatitis

- any severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or study drug
administration

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/09/2017
Sample size
Target
Accrual to date
Final
674
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Moorabin Campus - East Bentleigh
Recruitment postcode(s) [1] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Georgia
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United States of America
State/province [3] 0 0
Louisiana
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United States of America
State/province [4] 0 0
New York
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United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
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United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Jiangsu
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
China
State/province [12] 0 0
Zhejiang
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Chongqing
Country [15] 0 0
China
State/province [15] 0 0
Tianjin
Country [16] 0 0
Colombia
State/province [16] 0 0
Cundinamarca
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 5
Country [19] 0 0
Czechia
State/province [19] 0 0
Usti nad Labem
Country [20] 0 0
Denmark
State/province [20] 0 0
Aarhus C
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Marseille Cedex 09
Country [24] 0 0
France
State/province [24] 0 0
MONTPELLIER Cedex 5
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 15
Country [26] 0 0
France
State/province [26] 0 0
Rennes
Country [27] 0 0
France
State/province [27] 0 0
Saint Herblain
Country [28] 0 0
France
State/province [28] 0 0
Strasbourg
Country [29] 0 0
France
State/province [29] 0 0
Toulouse Cedex 9
Country [30] 0 0
France
State/province [30] 0 0
Tours Cedex 1
Country [31] 0 0
France
State/province [31] 0 0
Villejuif Cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Aachen
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Germany
State/province [33] 0 0
Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Homburg/Saar
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Germany
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Jena
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Germany
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Luebeck
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Germany
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Muenchen
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Germany
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Muenster
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Germany
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Nuernberg
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Germany
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Tuebingen
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Germany
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Ulm
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Greece
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Athens
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Greece
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Thessaloniki
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Ireland
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Dublin
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Ireland
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Galway
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Israel
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Petach-Tikva
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Israel
State/province [52] 0 0
Zerifin
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Italy
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Bologna
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Italy
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Chieti Scalo
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Italy
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Cremona
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggido, Korea, Republic OF
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Korea, Republic of
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Seoul Korea, Republic OF
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
State/province [63] 0 0
Seoul
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Malaysia
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Sarawak
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Mexico
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Gro.
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Warszawa
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Wroclaw
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Slovakia
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Bratislava
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Slovakia
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Martin
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Slovakia
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Zilina
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Spain
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Barcelona
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Spain
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A Coruna
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Lund
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Sweden
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Umea
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Sweden
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Uppsala
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Sweden
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Vasteras
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Switzerland
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Bern
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Switzerland
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St. Gallen
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Taiwan
State/province [85] 0 0
Taichung
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Taiwan
State/province [86] 0 0
Taipei
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United Kingdom
State/province [87] 0 0
Glasgow
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United Kingdom
State/province [88] 0 0
Guildford
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare the disease free survival time and safety of sunitinib with placebo in adjuvant
treatment patients at high risk of recurrent kidney cancer after surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00375674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries