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Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer

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: NCT00463060
Recruitment Status : Unknown
Verified June 2008 by Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
First Posted : April 19, 2007
Last Update Posted : June 19, 2008
Information provided by:
Icahn School of Medicine at Mount Sinai

Brief Summary:

Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).

Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.

Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.

Condition or disease Intervention/treatment Phase
Cancer Drug: sunitinib malate (Sutent) Procedure: radiotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Stereotactic Radiation Therapy and Concurrent and Adjuvant Sutent (SU11248) as Treatment for Oligometastatic Disease
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. survival

Secondary Outcome Measures :
  1. toxicity
  2. quality of life
  3. local control

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 years or older
  • Histologically or cytologically confirmed diagnosis of metastatic cancer
  • No prior RT to currently involved sites
  • Informed consent
  • ECOG performance status < 2
  • Intact organ and bone marrow function
  • Obtained informed consent

Exclusion Criteria:

  • Under 18 years of age

Information from the National Library of Medicine

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): NCT00463060

Contact: Johnny Kao, MD 212-241-7503
Contact: Stuart Packer, MD 212-241-8617

United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Johnny Kao, MD    212-241-7503   
Contact: Stuart Packer    212-241-8617   
Principal Investigator: Johnny Kao, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Johnny Kao, MD Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00463060     History of Changes
Other Study ID Numbers: GCO 06-0906
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: June 19, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors