Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer
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|ClinicalTrials.gov 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
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- quality of life
- local control
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 ClinicalTrials.gov identifier (NCT number): NCT00463060
|Contact: Johnny Kao, MD||212-241-7503||Johnny.email@example.com|
|Contact: Stuart Packer, MD||212-241-8617||stuart.packer@Mountsinai.org|
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Johnny Kao, MD 212-241-7503 Johnny.firstname.lastname@example.org|
|Contact: Stuart Packer 212-241-8617 stuart.packer@Mountsinai.org|
|Principal Investigator: Johnny Kao, MD|
|Principal Investigator:||Johnny Kao, MD||Icahn School of Medicine at Mount Sinai|