| A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Kidney Neoplasms |
- Drug: 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: 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
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| Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9. |
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| Active, not recruiting |
| 674 |
| August 17, 2017 |
| April 7, 2016 (Final data collection date for primary outcome measure) |
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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
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, China, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States |
| Austria, Czech Republic |
| |
| NCT00375674 |
A6181109
2006-004024-37 ( EudraCT Number )
S-TRAC ( Other Identifier: Alias Study Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| July 2017 |
