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Clinical Trials
What are clinical trials?
The following list represents current trials offered by the Department of Radiation Oncology. A brief description of the clinical trials is offered for referring physicians. If you think you are eligible for a trial, and would like to enroll, please have your doctor contact the Department of Radiation Oncology at (319) 384-9425.
IRB 200506744: A phase I clinical trial: 2-deoxyglucose + stereotactic radiosurgery (SRS) protocol for treatment of intracranial metastases. PI: Ken Dornfeld, MD, PhD.
This study seeks to determine the safest dose of a novel radiation enhancing drug, 2-deoxyglucose, when used with stereotactic radiosurgery for brain metastasis. Eligibility criteria includes using a bite plate for stereo-localization and a minimal age of 21 years. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200311079:A phase 1 study of fractionated radiation therapy combined with 2-deoxyglucose for treatment of squamous cell carcinoma of the head and neck. PI: Ken Dornfeld, MD, PhD.
This study seeks to determine the safest dose of a novel radiation enhancing drug, 2-deoxyglucose, when used with daily fractionated radiotherapy for head and neck cancer after surgery. Potential subjects must not be receiving chemotherapy and be at least 21 years of age. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200406002: Serial blood and salivary sampling for validation of quantitative amifostine assays. PI: Ken Dornfeld, MD, PhD.
This study seeks to validate a method of measuring amifostine levels in blood and saliva. All patients receiving amifostine and radiotherapy are eligible. . For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200502799: Biodistribution and radiation dosimetry of F-18 Flurothymidine (FLT) with Positron Emission Tomography (PET) in patients with head and neck cancer: a radioactive drug research committee (RDRC) study. PI: Ken Dornfeld, MD, PhD.
This study seeks to determine the biodistribution of FLT, a novel imaging agent for cancers, in patients with head and neck cancer. Patients being treated with (chemo)radiotherapy with cancers in a certain locations are eligible to participate. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200308067: Pilot study to evaluate esomeprazole (Nexium) in treating gastro-esophageal reflux in patients with head and neck cancer with prior external beam radiation therapy; a randomized, prospective, placebo-controlled, double-blind study. PI: Douglas Trask, MD, PhD.; Co-PI: Min Yao, MD, PhD
This study seeks to determine if gastroesophageal reflux occurs in a greater frequency in individuals treated prior with radiation therapy for head & neck cancer and if esomeprazole then effectively treats this condition. Eligibility criteria includes prior external radiation therapy to the head/neck and a minimum age of 18 years. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200408035: Treatment of adults with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma with surgery, Gliadel Wafers®, and limited field radiation plus concomitant temozolomide followed by adjuvant temozolomide PI: Timothy Ryken, MD; Co-PI: John Buatti, MD
This study seeks to validate a combinatorial therapeutic regimen for glioblastoma multiforme and anaplastic astrocytoma patients. Eligibility criteria include definitive diagnosis of glioblastoma multiforme or anaplastic astrocytoma. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB200211003: Development of radiation fibrosis in patients treated with pentoxifylline and vitamin E: a prospective randomized study . PI: Geraldine Jacobson, MD, MPH; Co-PI: Ken Dornfeld, MD, PhD.
This study seeks to determine the efficacy of using pentoxifylline combined with vitamin E in the prevention of radiation fibrosis. Eligibility criteria includes treatment for breast or head and neck cancer with radiation. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB200507777: CT-based planning of high dose rate tandem and ovoid applications
PI: Geraldine Jacobson, MD, MPH
This study seeks to determine the potential value of using CT for dosimetric planning of high-dose rate brachytherapy. Potential subjects should have confirmed carcinoma of the cervix or endometrium and deemed inoperable. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200505727: RTOG 0212—A phase II/III randomized trial of 2 doses (phase III-standard vs. high) and 2 high dose schedules (phase II-once vs. twice daily) for delivering prophylactic cranial irradiation for patients with limited disease small cell lung cancer. PI: Min Yao, MD, PhD
This is a multicenter, national trial organized by the Radiation Therapy Oncology Group to determine the best way to use radiotherapy to prevent spread of small cell lung cancer to the brain. Eligibility criteria include a normal CT/MRI one month prior to study and stable chest disease. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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IRB 200411779: RTOG 0214—A phase III comparison of prophylactic cranial irradiation versus observation in patients with locally advanced non-small cell lung cancer. PI: Min Yao, MD, PhD
This is a multicenter, national trial organized by the Radiation Therapy Oncology Group to determine if cranial irradiation is a valid method to prevent spread of cancer to the brain s for individuals with non-small cell lung cancer. Eligibility criteria include a normal CT/MRI one month prior to study and stable disease. For further information, physicians may contact the Radiation Oncology Clinical Trials office at (319) 384-9425.
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All clinical trials are governed by the Human Subjects Office at the University of IowaIf you have questions about the rights of research subjects or research related injury, please contact:
The Human Subjects Office
300 College of Medicine Administration Building
The University of Iowa
Iowa City IA 52242
(319) 335-6564
e-mail: irb@uiowa.edu
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