Stereotactic Body Radiotherapy (SBRT) and Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer (RCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672178
Recruitment Status : Terminated (Slow accrual)
First Posted : May 6, 2008
Results First Posted : December 15, 2010
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to determine the safety and efficacy of combined stereotactic body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All subjects will remain on sorafenib during SBRT.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Radiation: Stereotactic body radiation Phase 1 Phase 2

Detailed Description:

In the phase I portion of this investigation, subjects will be enrolled in cohorts of three to the SBRT dose groups. Subjects will remain on sorafenib therapy during SBRT. Any change in sorafenib dosage before, during or after SBRT will be at the discretion of the subject's medical oncologist. Subjects will be assessed during, immediately after and at 4 and 8 weeks post-therapy for toxicity.

Stereotactic body radiotherapy will be given in increasingly higher dose levels each cohort until the maximum tolerated dose of radiation is determined.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Radiation: Stereotactic body radiation
    Stereotactic body radiotherapy will be given in three cohorts of increasingly higher dose levels: Cohort 1: 6 Gy/fraction x 3 fractions (total=18 Gy) over 5 days; Cohort 2: 8 Gy/fraction x 3 fractions over 5 days; Cohort 3: 10 Gy/fraction x 3 fractions over 5 days.

Primary Outcome Measures :
  1. Number of Participants With Overall Complete and Partial Response (CR+PR) [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years old
  • Zubrod Performance Status 0 or 1
  • Adequate bone marrow, liver and renal function as assessed by the following:

    • Hemoglobin > 9.0 g/dl
    • Absolute neutrophil count (ANC) > 1,500/mm3
    • Platelet count > 100,000/mm3
    • Total bilirubin < 1.5 times institutional upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the institutional ULN
    • Creatinine < 1.5 times institutional ULN
  • Histologically or cytologically confirmed renal cell carcinoma, which is metastatic, unresectable or recurrent.
  • Life expectancy > 6 months
  • Local recurrence or progression of primary lesion or progression, or symptomatic progression in extra-cranial, extra-pulmonary metastases while on sorafenib
  • Measurable disease
  • Bone metastases must have a tissue component measurable by imaging.
  • No untreated brain metastases
  • Resolution of pre-existing toxicity from prior therapy excluding alopecia and taste alteration.
  • Willingness and ability to comply with continuing sorafenib, visits, treatment plans, laboratory tests and study procedures.
  • All treated lesions must comply with SBRT dose constraints
  • More than 28 days since any prior systemic or local therapy for this cancer, including investigational agents and surgical procedures exclusive of sorafenib
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control)
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
  • Ability to understand and the willingness to sign a written informed consent.
  • Prothrombin time(PT) and partial thromboplastin time (PTT) within normal limits.

Exclusion Criteria:

  • Lesion in remaining (solo) kidney
  • Contraindications to radiotherapy or prior radiotherapy overlapping current site(s) of disease.
  • Cardiac disease: Congestive heart failure. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Active clinically serious infection
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding problems
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
  • Any malabsorption problem.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672178

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: John Kirkpatrick, MD Duke University

Responsible Party: Duke University Identifier: NCT00672178     History of Changes
Other Study ID Numbers: Pro00001398
First Posted: May 6, 2008    Key Record Dates
Results First Posted: December 15, 2010
Last Update Posted: January 12, 2017
Last Verified: January 2011

Keywords provided by Duke University:

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action