NCT01481870

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

3.5 years

First QC Date

November 17, 2011

Last Update Submit

February 21, 2013

Conditions

Metastatic Renal Cell Carcinoma

Keywords

renal cell carcinomasorafenibsunitinibcrossover

Outcome Measures

Primary Outcomes (1)

  • 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.

    Time of progression in first line treatment

Secondary Outcomes (1)

  • Total progression free survival (PFS) in first-line and second-line treatments

    Time of progression in second line treatment

Study Arms (2)

Sorafenib-sunitinib

ACTIVE COMPARATOR

Sorafenib is first line treatment followed by sunitinib.

Drug: Sorafenib-sunitinib

Sunitinib-sorafenib

ACTIVE COMPARATOR

Sunitinib is first line treatment followed by sorafenib.

Drug: Sunitinib-sorafenib

Interventions

Sorafenib-sunitinibDRUG

sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed

Sorafenib-sunitinib
Sunitinib-sorafenibDRUG

sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed

Sunitinib-sorafenib

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yamagata University Faculty of Medicine

Yamagata, 990-9585, Japan

Location

Related Publications (3)

  • 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.

    PMID: 20713418BACKGROUND

  • Aldin 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.

    PMID: 37146227DERIVED

  • Tomita 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.

    PMID: 32466961DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Yoshihiko Tomita, MD

    Yamagata University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Head of Department of Urology

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 30, 2011

Study Start

January 1, 2010

Primary Completion

July 1, 2013

Study Completion

December 1, 2015

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

JP(1)