Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)

June 21, 2011 updated by: Korean Urological Oncology Society

Neoadjuvant Sunitinib Therapy in Patients With Metastatic Clear Cell Type Renal Cell Carcinoma Patients: a Prospective Study

The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces the size of the primary kidney tumor in patients with metastatic disease undergoing cytoreductive surgery. The study will also assess the safety of neoadjuvant Sunitinib, objective response rate, respectability of primary tumor, quality of life, and survival advantages.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary objectives :

1. Response rate of primary tumor based on RECIST criteria

Secondary objectives :

  1. Resectability based on R0 resection rate (negative margin)
  2. Toxicities of therapy with neoadjuvant Sunitinib in renal cell carcinoma
  3. Quality of life assessed by EORTC QLQ-C30 questionnaire Korean version
  4. To assess the efficacy of neoadjuvant therapy of Sunitinib by evaluating time to progression
  5. Overall survival rate after Sunitinib therapy
  6. Pathologic evaluation after Sunitinib therapy: the change of necrosis and microvessel density

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

  • Name: Jinsoo Chung, M.D.,Ph.D
  • Phone Number: +82-31-920-2456
  • Email: cjs5225@ncc.re.kr

Study Locations

  • Korea, Republic of
      • Cheonju, Korea, Republic of, 361-711
        • Recruiting
        • Chungbuk University Hospital
        • Contact:
          • Wun-Jae Kim, M.D., Ph.D.
      • Seoul, Korea, Republic of, 137-710
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Hyun Moo Lee, M.D.,Ph.D.
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy proven RCC with a component of clear cell type histology
  • Clinical stage TxNxM+
  • At least one site of measurable disease as defined by RECIST criteria
  • Potential candidates for cytoreductive nephrectomy
  • Favorable or intermittent risk group according to MSKCC risk factor model
  • ECOG performance status 0 or 1

  • Adequate organ function as defined by:

    • AST or ALT less than or equal to 2.5 times the upper limit of normal
    • Bilirubin less than or equal to 1.5 times the upper limit of normal
    • Absolute neutrophil count (ANC) greater than or equal to 1500/mL
    • Platelets greater than or equal to 100,000/mL
    • Hemoglobin greater than or equal to 9.0 g/dL
    • Serum calcium less than or equal to 12.0 mg/dL
    • Serum creatinine less than or equal to 1.5 times the upper limit of normal
  • Male or female, 18 years of age or older
  • Women of childbearing potential must NOT be pregnant (as confirmed by a negative pregnancy test)
  • Signed informed consent form indicating that the patient or acceptable representative has been informed of all parts of the trial prior to Sunitinib administration (enrollment)
  • Willingness and ability to comply with study procedures

Exclusion Criteria:

  • History of another primary malignancy within 5 years, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
  • NCI CTCAE grade 3 hemorrhage within 4 weeks of commence of Sunitinib therapy.
  • Presence of brain metastases during screening period
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade of 2 or more, atrial fibrillation of any grade or prolongation of QTc interval to more than 450 millisecond (msec) for male or more than 470 msec for female
  • Hypertension that cannot be controlled by medications
  • Concurrent treatment with therapeutic doses of coumadin but low dose of coumadin up to 2 mg orally daily for deep vein thrombosis prophylaxis is allowed.
  • Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials are allowed.
  • Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
  • Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing before 7 and 12 days before date of randomization.
  • Other severe acute or chronic medical or psychiatric condition of laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
  • Any of the following within 12 months prior to study drug administration:

severe/unstable angina, myocardiac infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.

  • Known hypersensitivity to Sunitinib
  • Women who are breast-feeding ※ Note At screening, resectability of primary tumor itself does not influence on patients enrollment. Physicians only have to describe about the resectability ("resectable" or "unresectable") at screening on their own discretion, but if they decide that primary tumor is "unresectable", the should specify reasons for unresectable status as follows: invasion into neighboring organs, proximity to vital structure or vessels, bulky regional lymph nodes, vascular invasion, burden of metastatic disease, and others.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Time Frame: within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off)
within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate after Sunitinib therapy
Time Frame: 2 years
2 years
Pathologic evaluation after Sunitinib therapy
Time Frame: After nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)
After nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)
Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire (Korean version)
Time Frame: 2 years
2 years
Resectability based on R0 resection rate
Time Frame: on nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)
on nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)

Collaborators and Investigators

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

Sponsor

Korean Urological Oncology Society

Collaborators

Pfizer

Investigators

  • Principal Investigator: Sungjoon Hong, M.D., Ph.D, The Korean Urological Oncology Society

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.

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

July 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (ESTIMATE)

February 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sutent-IIR

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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