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Clinical Trials

Bladder

RTOG 0524 A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab with Daily Irradiation or Paclitaxel Alone with Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates with Muscle-Invasive Bladder Cancer (P.I.: Howard Sandler,coordinator: Stacy Ahmad); IRB # HUM5459. (Phase I/II) Not open at other hospitals.

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Brain

UMCC 2-66, Phase I Study of Concurrent Temozolomide and 3D Conformal Radiotherapy Dose Escalation for Treatment of Primary Glioblastoma Multiforme (P.I.: Christina Tsien,coordinator: Kristin Brierley); IRB # 2003-0081. (Phase I) Not open at other hospitals.

UMCC 3-23, Phase I Study of Concurrent Gemcitabine and Radiotherapy (RT) for Malignant High Grade Gliomas (P.I.: Christina Tsien,coordinator: Kristin Brierley); IRB # 2004-0350. (Phase I)  Also open at Ingham.

UMCC 2005.003, MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients with Brain Metastases During and Afer Radiotherapy (P.I.: Yue Cao,coordinator: Kristin Brierley); IRB # 2005-0229. (Pilot) Not open at other hospitals.  

UMCC 2007.047, Assessment of Neuronal Synaptic CNS Markers by Neurotransmitter PET in Patients with Neuro-Cognitive Decline After Radiation Treatment (P.I.: Christina Tsien,coordinator: Kristin Brierley); HUM # 12703. Not open at other hospitals.

RTOG 0320, A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases (P.I.: Jim Hayman, coordinator: Stacy Ahmad); IRB # HUM00000628. (Phase III) Not open at other hospitals.

RTOG 0625, A Randomized Phase II Trial of Bevacizumab with Irinotecan or Bevacizumab with Temozolomide in Recurrent Glioblastoma (P.I.: Christina Tsien, coordinator: Stacy Ahmad); IRB# HUM14405. (Phase II) Not open at other hospitals.

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Breast

UMCC 2004.038, A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer. (P.I.: Lori Pierce, coordinator: Jody Sharp); IRB #2002-0387. (Phase II). Also open at Providence Hospitals Novi and Southfield.

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Esophagus

SWOG S0414, Cetuximab Plus Cisplatin, Irinotecan, and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates. (P.I. Susan Urba, coordinator: Barb Keller (of SWOG) phone: 8-7146); IRB #2005-0488.

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Gynecological

RTOG 0418, A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma. (P.I.: Charlie Pan, coordinator: Stacy Ahmad); IRB # HUM00005260. (Phase II) Not open at other hospitals. Note: Endometrial Arm closed to new patient accrual.

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Head and Neck

UMCC 2-21, Optimized Intensity Modulated Irradiation for Head and Neck Cancer. (P.I. Avraham Eisbruch, coordinator: Kate Keever); IRB# 2002-513. (Phase II) Not open at other hospitals.

UMCC 2004-024, A Pilot Study of [18F] FLT-PET in Patients with Head and Neck Cancer Undergoing Chemo-Irradiation. (P.I. Avraham Eisbruch, coordinator: Kate Keever); IRB# 2004-631. (Pilot Study) Not open at other hospitals.

UMCC 2005.097 , Cross-Sectional Study of Oral Health in Patients after Parotid-Sparing Radiation Therapy for Head-And-Neck Cancer. (P.I. Avraham Eisbruch, coordinator: Kate Keever); IRB# HUM00000970. Not open at other hospitals.

UMCC 2005.065, Pilot Study to Assess EGFR Inhibition by Erlotinib in Tumors as Compared with Normal Mucosa in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck. (P.I. Christina Tsien, coordinator: Kate Keever); IRB# HUM00001390. Not open at other hospitals.

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Liver

UMCC 2-8, Phase I Trial of Dose Escalated Whole Liver Irradiation with Hepatic Arterial Floxuridine/Leucovorin/Streptozotocin Chemotherapy Followed Subsequently by Chemoembolization with Mitomycin-C for Patients with Neuroendocrine Hepatic Metastases. (P.I.: William Ensminger,coordinator: Monika Benedict); IRB # 2002-0256. (Phase I) Not open at other hospitals.

UMCC 2003.081, Assessment of Liver Function in Patients Undergoing Hepatic Irradiation. (P.I.: Charlie Pan,coordinator: Monika Benedict); IRB # 2004-0023. (Pilot) Not open at other hospitals.

UMCC 2006.067, A Pilot Study of Radiation Toxicity Using MRI-Based Perfusion. (P.I.: Charlie Pan, coordinator: Monika Benedict-Blue); IRB # HUM5910. (Pilot) Not open at other hospitals.

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Lung

UMCC 2007.123, Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients with Non-Small Cell Lung Cancer. (P.I.: Spring Kong, coordinator: Jody Sharp). IRB #HUM15709.

UMCC 2006.040, Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Non-Small Cell Lung Cancer. (P.I.: Spring Kong, coordinator: Jody Sharp); IRB # HUM2913. (Phase II) Also open at VA.

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Pancreas

UMCC 2006.018, A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) with Concurrent Gemcitabine in Patients with Unresectable Pancreatic Cancer. (P.I.: Edgar Ben-Josef, coordinator: Monika Benedict-Blue); IRB # HUM3315. (Phase I/II) Not open at other UM sites: Open at RushUniversityMedicalCenter.

UMCC 2006.025, A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin with Radiation Therapy in Patients with Pancreatic Cancer. (P.I.: Mark Zalupski, coordinator: Monika Benedict-Blue); IRB # HUM4531. Not open at other U-M Radonc hospitals. Open at 3 other hospitals (John Hopkins, OhioState, Princess Margaret)

UMCC 2007.017, A Pilot Study of [18F] FLT-PET In Patients With Resectable Pancreatic Cancer Undergoing Neoadjuvant Chemoradiotherapy. (P.I. Edgar Ben-Josef, coordinator: Monika Benedict-Blue); IRB # HUM10655. Not open at other hospitals.

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Prostate 

UMCC 2006.066, Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure after Radical Prostatectomy (PI: Howard Sandler, coordinator: Kristin Brierley); IRB #HUM00007093. (Phase II) Not open at other hospitals.

UMCC 2005.015, A Pilot Trial To Determine The Effect Of Intratreatment Organ Motion On The Minimum Dose To The Prostate During External Beam Prostate Radiotherapy (PI: Howard Sandler, coordinator: Kristin Brierley); IRB #2005-302. (Pilot) Not open at other hospitals.

RTOG 0126, A Phase III Randomized Study of High Dose 3D-CRT versus Standard Dose 3D-CRT in Patients Treated for Localized Prostate Cancer (P.I.: Howard Sandler,coordinator: Stacy Ahmad); IRB #2002-0558. (Phase III) Also open at the VA and Foote hospitals.

RTOG 0521, A Phase III Protocol of Androgen Suppression (AS) and 3DRT/IMRT VS AS And 3DRT/IMRT Followed By Chemotherapy With Docetaxel And Prednisone For Localized, High-Risk Prostate Cancer (P.I.: Howard Sandler,coordinator: Stacy Ahmad); IRB #HUM00003447. (Phase III) Also open at Ingham.

UMCC 2007.035, Serum Bank for Intermediate and High Risk Prostate Cancer Patients (P.I. Daniel Hamstra, coordinator: Jody Sharp); IRB# HUM00011697. Not open at other hospitals.

RTOG 0415, A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients With Favorable-Risk Prostate Cancer (P.I.: Howard Sandler, coordinator: Stacy Ahmad); IRB# HUM14492. Not open at other hospitals.

RTOG 0534, A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy (P.I.: Howard Sandler, coordinator: Stacy Ahmad); IRB#HUM18101. Not open at other hospitals.

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Rectal

UMCC 2006.005, Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy. (P.I.: Edgar Ben-Josef,coordinator: Kristin Brierley); IRB # HUM00003606. (QOL) Open at Johns Hopkins, Prov, and Mt. Pleasant.

UMCC 2006.028, Validation of the EORTC QLQ-CR29 Quality of Life form in Rectal Cancer Patients Receiving Chemo-Radiotherapy. (P.I.: Edgar Ben-Josef,coordinator: Kristin Brierley); IRB # HUM00004830. (QOL) Not open at other hospitals.

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