Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma (CROSS-J-RCC)

February 21, 2013 updated by: Yoshihiko TOMITA, Yamagata University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Yamagata, Japan, 990-9585
        • Yamagata University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. Respiratory function: %VC, 80% and FEV1.0,70%
    2. Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
    3. Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin <1.5 x ULN
    4. Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl
    5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time of progression in first line treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total progression free survival (PFS) in first-line and second-line treatments
Time Frame: Time of progression in second line treatment
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.
Time of progression in second line treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yamagata University

Investigators

  • Principal Investigator: Yoshihiko Tomita, MD, Yamagata University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROSS-J-RCC
  • UMIN000003040 (Other Identifier: Japanese University Hospital Medical Informaton Network (UMIN))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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