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

Phase 2
18 Years
Open (Enrolling)
Clear Cell Renal Cell Carcinoma, Metastasis

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Trial Information

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

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

5. Overall survival rate after Sunitinib therapy

6. Pathologic evaluation after Sunitinib therapy: the change of necrosis and microvessel

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Outcome 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)

Safety Issue:


Principal Investigator

Sungjoon Hong, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Korean Urological Oncology Society


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

June 2012

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Metastasis
  • Neoadjuvant Therapy
  • Sunitinib
  • Clear Cell Renal Cell Carcinoma
  • Metastasis
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis