SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC - ND

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2006-004024-37-IT
• Date of registration: 21/02/2008
• Prospective Registration: No
• Primary sponsor: PFIZER
• Public title: SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC - ND
• Scientific title: SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC - ND
• Date of first enrolment: 19/12/2007
• Target sample size: 275
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004024-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1.Subjects must sign and date IRB/IEC-approved informed consent
2. Age >/= 18 years
3. ECOG Performance Status 0 ? 2 prior to nephrectomy
4. Subjects must be diagnosed in the high risk UISS staging system with one of the
following:
a. T3 N0 or Nx, M0, Fuhrman?s grade >/= 2 and ECOG general status >/= 1, or
b. T4 N0 or Nx, M0, any Fuhrman?s grade and any ECOG general status, or
c. Any T, N1-2, M0, any Fuhrman?s grade and any ECOG general status
3.
5. Subjects must have histologically confirmed preponderant clear cell RCC
6. Subjects must have no evidence of macroscopic residual disease or metastatic disease
Subjects having evidence for microscopic disease (R1) are acceptable
7. Subjects must not have received any specific medical previous systemic treatment for
RCC
8. Subjects must not have received any previous anti-angiogenic treatment
9. Subjects must receive the first oral dose of sunitinib not more than 10 weeks after
date of nephrectomy (see Appendix 6 for Nephrectomy Procedure).
10. Subjects must have adequate organ function defined as:a. Platelets >/= 100 x 10(9)/L, hemoglobin >/= 8 g/dl, absolute neutrophil count (ANC)
>/=1.5 x 10(9)/L;
b. Bilirubin (ALT) c. International Normalize Ratio (INR) d. Calculated creatinine clearance >/= 30 ml/min.
11. Sufficient left ventricular ejection function (LVEF) defined as >/=50% 3 to 10 weeks
after date of nephrectomy based on 2-D echocardiogram (ECHO) or multigated
acquisition MUGA
12. Women and men must use adequate contraception during the study. Acceptable
contraception includes implants, injectables, combined oral contraceptives, effective
intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner or
vasectomy. 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
sarcoma or subjects with metastatic renal sites.
2. NCI CTCAE grade 3 hemorrhage <4 weeks of date of randomization.
3. Diagnosis of any second malignancy within the 5 years from date of randomization,
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.
4.Any of the following within the 12 months prior to study drug administration:
severe/unstable angina, myocardial infarction, coronary artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident, including transient
ischemic attack, or pulmonary embolism.
5. Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or
dosing before 7 and 12 days before date of randomization (e.g., ketoconazole,
rifampin, etc. respectively).
6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation of any
grade, or prolongation of the QTc interval to > 500 msec.
7.Hypertension that cannot be controlled by medications.
8.Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin
currently or within 2 weeks prior to first day of sunitinib administration. Low dose
warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (up to 2 mg/day).
Low molecular weight heparin or aspirin are allowed.
9.Inability to swallow oral medications, or presence of active inflammatory bowel
disease, partial or complete bowel obstruction or chronic diarrhea.
10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS)-related illness.
11.Known active hepatitis.
12.Pregnancy or breastfeeding. All female subjects with reproductive potential must
have a negative pregnancy test (serum or urine) within the 7 days prior to date of randomization.
13.Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and in
the judgment of the investigator would make the subject inappropriate for entry into this study.
14.Receipt of any investigational oncology or, approved or investigational antiangiogenic
agent prior to study entry.
15.Current treatment on another therapeutic clinical trial. Supportive care trials or nontreatment
trials, e.g. PRO methods studies, are allowed.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Adjuvant treatment of subjects with ?high risk? Renal Cell Carcinoma (RCC) following nephrectomy.
MedDRA version: 9.1 Level: LLT Classification code 10038458 Term: Renal granular cell carcinoma

Intervention(s)

Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib Malate
CAS Number: 341031-54-7
Current Sponsor code: SU-0011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib Malate
CAS Number: 341031-54-7
Current Sponsor code: SU-0011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Compare overall survival (OS) associated with Arm A to that associated with Arm B
Assess safety/toxicity profile of schedule 4/2: 4 weeks on, 2 weeks off administration of
sunitinib
Assess patient reported outcomes (PROs)
Assess the UISS Prognostic Model

Primary end point(s): Disease Free Survival: (DFS), defined as the time interval from the date of randomization to
the first date of recurrence or occurrence of a secondary malignancy or death. The primary
DFS analysis will be based on independent blinded 3rd party review. A secondary analysis of
DFS will be based on the local investigator assessment.
Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. The date of
recurrence or occurrence of a secondary malignancy is defined as the date of the independent
blinded 3rd party review confirms recurrence or occurrence of a secondary malignancy for the
first time.
For subjects receiving further anti-tumor therapy before disease recurrence or occurrence of a
secondary malignancy or death, the subjects will be assigned with DFS events at the first date
of recurrence or occurrence of secondary malignancy or death. In the absence of DFS event,
DFS time will be censored at the date of last disease assessment or cutoff date, whichever
come first. Subjects alive who do not have post baseline disease assessment will have their
DFS times censored at Day 1.

Main Objective: To demonstrate an improvement in disease-free survival (DFS) in high risk (per modified
UISS criteria) subjects with RCC randomly assigned to adjuvant sunitinib 50 mg schedule
4/2: 4 weeks on, 2 weeks off for 1 year (Arm A), vs. Placebo (Arm B) after nephrectomy.

Secondary ID(s)

2006-004024-37-FR

A6181109

Ethics review

Status: Approved
Approval date: 19/08/2007
Contact:

Results

• Results available: Yes
• Date Posted: 23/03/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-004024-37/results