Metastatic Renal Cell CarcinomaPhase 3CROSS-J-RCCNCT01481870
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
A Phase 3 study testing Sorafenib-sunitinib and Sunitinib-sorafenib in people with Metastatic Renal Cell Carcinoma, run by Yamagata University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sorafenib-sunitinib and Sunitinib-sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sorafenib-sunitinib, Sunitinib-sorafenib
- Keywords
- renal cell carcinoma, sorafenib, sunitinib, crossover
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib-sunitinibDrug
sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
Sunitinib-sorafenibDrug
sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib-sunitinib | Active comparator | Sorafenib is first line treatment followed by sunitinib. Receives: Drug: Sorafenib-sunitinib |
| Sunitinib-sorafenib | Active comparator | Sunitinib is first line treatment followed by sorafenib. Receives: Drug: Sunitinib-sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival in first-line treatment
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.
Measured: Time of progression in first line treatment
Secondary outcomes (1)
Total progression free survival (PFS) in first-line and second-line treatments
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.
Measured: Time of progression in second line treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yamagata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiko TOMITA, Yamagata University
- Investigators
- Yoshihiko Tomita, MD, Principal investigator, Yamagata University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481870
- Sponsor's protocol ID
- CROSS-J-RCC
- Other IDs
- UMIN000003040
- Acronym
- CROSS-J-RCC
- Status last verified
- Feb 2013
- First submitted
- 17 Nov 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tomita Y, Shinohara N, Yuasa T, Fujimoto H, Niwakawa M, Mugiya S, Miki T, Uemura H, Nonomura N, Takahashi M, Hasegawa Y, Agata N, Houk B, Naito S, Akaza H. Overall survival and updated results from a phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma. Jpn J Clin Oncol. 2010 Dec;40(12):1166-72. doi: 10.1093/jjco/hyq146. Epub 2010 Aug 16.
PubMed 20713418Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PubMed 37146227Tomita Y, Naito S, Sassa N, Takahashi A, Kondo T, Koie T, Obara W, Kobayashi Y, Teishima J, Takahashi M, Matsuyama H, Ueda T, Yamaguchi K, Kishida T, Shiroki R, Saika T, Shinohara N, Oya M, Kanayama HO. Sunitinib Versus Sorafenib as Initial Targeted Therapy for mCC-RCC With Favorable/Intermediate Risk: Multicenter Randomized Trial CROSS-J-RCC. Clin Genitourin Cancer. 2020 Aug;18(4):e374-e385. doi: 10.1016/j.clgc.2020.01.001. Epub 2020 Mar 6.
PubMed 32466961
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01481870
- Acronym / sponsor ID
- CROSS-J-RCC / CROSS-J-RCC
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, sorafenib, sunitinib, crossover
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yamagata UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib-sunitinib | Active comparator | Drug: Sorafenib-sunitinibSorafenib is first line treatment followed by sunitinib. |
| Sunitinib-sorafenib | Active comparator | Drug: Sunitinib-sorafenibSunitinib is first line treatment followed by sorafenib. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib-sunitinibsorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed | Drug | Sorafenib-sunitinib |
| Sunitinib-sorafenibsunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed | Drug | Sunitinib-sorafenib |
Primary outcome
Progression free survival in first-line treatment
Time frame: Time of progression in first line treatment
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.
1 secondary outcome
Total progression free survival (PFS) in first-line and second-line treatments
Time frame: Time of progression in second line treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Background: PubMed 20713418Tomita Y, Shinohara N, Yuasa T, Fujimoto H, Niwakawa M, Mugiya S, Miki T, Uemura H, Nonomura N, Takahashi M, Hasegawa Y, Agata N, Houk B, Naito S, Akaza H. Overall survival and updated results from a phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma. Jpn J Clin Oncol. 2010 Dec;40(12):1166-72. doi: 10.1093/jjco/hyq146. Epub 2010 Aug 16.
- Derived from this study: PubMed 37146227Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
- Derived from this study: PubMed 32466961Tomita Y, Naito S, Sassa N, Takahashi A, Kondo T, Koie T, Obara W, Kobayashi Y, Teishima J, Takahashi M, Matsuyama H, Ueda T, Yamaguchi K, Kishida T, Shiroki R, Saika T, Shinohara N, Oya M, Kanayama HO. Sunitinib Versus Sorafenib as Initial Targeted Therapy for mCC-RCC With Favorable/Intermediate Risk: Multicenter Randomized Trial CROSS-J-RCC. Clin Genitourin Cancer. 2020 Aug;18(4):e374-e385. doi: 10.1016/j.clgc.2020.01.001. Epub 2020 Mar 6.
- UMIN Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihiko Tomita, MD principal investigator
Yamagata University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sorafenib-sunitinib and Sunitinib-sorafenib in people with Metastatic Renal Cell Carcinoma, run by Yamagata University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival in first-line treatment (time frame: Time of progression in first line treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481870, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.