A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00375674
• Date of registration: 12/09/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• 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 S-TRAC
• 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
• Date of first enrolment: August 1, 2007
• Target sample size: 674
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00375674
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, China, Colombia, Czech Republic, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Neoplasms

Intervention(s)

Drug: Sunitinib malate

Other: Placebo

Primary Outcome(s)

Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review [Time Frame: 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.]

DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population] [Time Frame: 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(s)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity [Time Frame: 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]

PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population [Time Frame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)]

Number of Participants With Tolerability Symptoms [Time Frame: 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]

Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population) [Time Frame: Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)]

PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison [Time Frame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)]

Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles) [Time Frame: 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]

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 [Time Frame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)]

PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison [Time Frame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)]

PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means [Time Frame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)]

Secondary ID(s)

2006-004024-37

A6181109

S-TRAC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/08/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00375674