NCT00570882

Brief Summary

This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

6.7 years

First QC Date

December 10, 2007

Last Update Submit

September 22, 2014

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal cell carcinomaSunitinibphase II studyRandomized study

Outcome Measures

Primary Outcomes (1)

  • Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)

    From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.

    12 months

Secondary Outcomes (5)

  • Overall response rate

    6 months

  • quality of life

    12 months

  • Progression free survival

    12 months

  • Overall survival

    36 months

  • Adverse events

    about 12 months

Study Arms (2)

Sunitinib 4/2

ACTIVE COMPARATOR

Sunitinib 50 mg PO 4-week on and 2-week off

Drug: Sunitinib 4/2

Sunitinib 2/1

EXPERIMENTAL

Sunitinib 50 mg PO 2-week on 1-week off

Drug: Sunitinib 2/1

Interventions

Sunitinib 2/1DRUG

Sunitinib 50 mg PO 2 weeks followed by 1 week rest

Sunitinib 2/1
Sunitinib 4/2DRUG

Sunitinib 50 mg PO 4 weeks followed by 2 week rest

Sunitinib 4/2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component
  • Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
  • Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
  • ECOG performance status 2 or better
  • Age 18 years or older
  • Adequate bone marrow, hepatic, and renal function
  • Life expectancy of \> 3 months
  • Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

You may not qualify if:

  • Known spinal cord compression or carcinomatous meningitis
  • Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
  • Hypertension that cannot be controlled by medications (blood pressure \> 150/90 mmHg despite optimal medical therapy)
  • Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
  • Pregnancy or breast feeding.
  • Other severe acute or chronic medical or psychiatric condition
  • Prior treatment on sunitinib, sorafenib, or bevacizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Daegu Catholic University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Lee JL, Kim MK, Park I, Ahn JH, Lee DH, Ryoo HM, Song C, Hong B, Hong JH, Ahn H. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015 Nov;26(11):2300-5. doi: 10.1093/annonc/mdv357. Epub 2015 Sep 7.

    PMID: 26347107DERIVED

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

  • Jae-Lyun Lee, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

KR(3)