Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma (CROSS-J-RCC)
This study is ongoing, but not recruiting participants.
Sponsor:
Yamagata University
Information provided by (Responsible Party):
Yoshihiko TOMITA, Yamagata University
ClinicalTrials.gov Identifier:
NCT01481870
First received: November 17, 2011
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Renal Cell Carcinoma |
Drug: Sorafenib-sunitinib Drug: Sunitinib-sorafenib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Yamagata University:
Primary Outcome Measures:
- Progression free survival in first-line treatment [ Time Frame: Time of progression in first line treatment ] [ Designated as safety issue: No ]From date of randomization until the date of first documented progression of the first line treatment or date of death from any cause, whichever came first, assessed up to 36 months.
Secondary Outcome Measures:
- Total progression free survival (PFS) in first-line and second-line treatments [ Time Frame: Time of progression in second line treatment ] [ Designated as safety issue: No ]From date of randomization until the date of first documented progression of the second line treatment or date of death from any cause, whichever came first, assessed up to 36 months.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sorafenib-sunitinib
Sorafenib is first line treatment followed by sunitinib.
|
Drug: Sorafenib-sunitinib
sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
|
|
Active Comparator: Sunitinib-sorafenib
Sunitinib is first line treatment followed by sorafenib.
|
Drug: Sunitinib-sorafenib
sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age: 20-80 years old, both inclusive
- ECOG performance status of 0, 1, or 2
- MSKCC risk of favorable or intermediate
- Histologically confirmed renal cell carcinoma
- No ischemic heart disease
Laboratory findings meet the following criteria:
- Respiratory function: %VC, 80% and FEV1.0,70%
- Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
- Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin <1.5 x ULN
- Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl
- Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.
Exclusion Criteria:
- History of any other malignancy
- Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study, and require no corticosteroids may be enrolled.
- History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment
- History of cerebrovascular disorder including transient ischemic attack (TIA)
- Pregnancy or possible pregnancy at any time during the study
- Ongoing grade 2 adverse event prior treatment
- Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2
- Prior treatment with mTOR inhibitor
- Prior treatment with sunitinib or sorafenib
- Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481870
Locations
| Japan | |
| Yamagata University Faculty of Medicine | |
| Yamagata, Japan, 990-9585 | |
Sponsors and Collaborators
Yamagata University
Investigators
| Principal Investigator: | Yoshihiko Tomita, MD | Yamagata University Faculty of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Yoshihiko TOMITA, Clinical Professor, Head of Department of Urology, Yamagata University |
| ClinicalTrials.gov Identifier: | NCT01481870 History of Changes |
| Other Study ID Numbers: | CROSS-J-RCC, UMIN000003040 |
| Study First Received: | November 17, 2011 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Yamagata University:
|
renal cell carcinoma sorafenib sunitinib crossover |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Sorafenib |
Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013