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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Sorafenib-sunitinib
Sunitinib-sorafenib
Sponsored by
Yamagata University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring renal cell carcinoma, sorafenib, sunitinib, crossover

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yamagata University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sorafenib-sunitinib

Sunitinib-sorafenib

Arm Description

Sorafenib is first line treatment followed by sunitinib.

Sunitinib is first line treatment followed by sorafenib.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 17, 2011
Last Updated
February 21, 2013
Sponsor
Yamagata University
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1. Study Identification

Unique Protocol Identification Number
NCT01481870
Brief Title
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Acronym
CROSS-J-RCC
Official Title
Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yamagata University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
renal cell carcinoma, sorafenib, sunitinib, crossover

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib-sunitinib
Arm Type
Active Comparator
Arm Description
Sorafenib is first line treatment followed by sunitinib.
Arm Title
Sunitinib-sorafenib
Arm Type
Active Comparator
Arm Description
Sunitinib is first line treatment followed by sorafenib.
Intervention Type
Drug
Intervention Name(s)
Sorafenib-sunitinib
Intervention Description
sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
Intervention Type
Drug
Intervention Name(s)
Sunitinib-sorafenib
Intervention Description
sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed
Primary Outcome Measure Information:
Title
Progression free survival in first-line treatment
Description
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 Frame
Time of progression in first line treatment
Secondary Outcome Measure Information:
Title
Total progression free survival (PFS) in first-line and second-line treatments
Description
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 Frame
Time of progression in second line treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshihiko Tomita, MD
Organizational Affiliation
Yamagata University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yamagata University Faculty of Medicine
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20713418
Citation
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.
Results Reference
background
PubMed Identifier
32466961
Citation
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.
Results Reference
derived
Links:
URL
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000003325&language=J
Description
UMIN Clinical Trial Registry

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Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

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