DESCRIPTION (provided by applicant): The principal objective of the Geisinger Clinical Oncology Program is to enroll a maximum number of participants onto NCI-approved cancer prevention, cancer control and cancer treatment protocols, bringing research-quality cancer care to a large rural population of Pennsylvania. The Geisinger Health System serves more than 2.3 million Pennsylvanians across 31 primarily rural counties in the central and northeastern parts of the state. This Health System includes a 535 physician primary and multispecialty group practice in 45 sites, anchored by the 437 bed tertiary care Geisinger Medical Center in Danville, the largest rural tertiary center in the U.S. The other major hubs of the System are in State College (90-member multispecialty group) and Wilkes-Barre (160 bed hospital with 100-member multispecialty group). These hubs will each be an important CCOP site as well. Geisinger Health system operates a staff model HMO with nearly 300,000 members that works cooperatively with the CCOP to promote cancer prevention trials. Among Geisinger's advantages are a stable and growing CCOP staff with a history of excellent retention of personnel and with successful performance over the 19 year history of the NCI CCOP program. The system enjoys a large network of primary care practices, with all practices and all physicians (including specialists) linked by a state-of-art electronic medical record (EPIC-Care), and a large cancer patient population (over 2000 new analytic cases/year). The addition of new System C.E.O. Dr. Glenn Steele, a prominent academic surgical oncologist and researcher, has given new emphasis to the institutional commitment to growing cancer research. The System has been reorganized into Service Lines, which has greatly aided the Cancer Service Line, Geisinger Cancer Institute, in recruiting and building in all three major hub sites. Clinical trial performance is enhanced by a new computerized clinical protocol management system (Protonet), a System-wide cancer registry that includes all outpatient as well as all hospital sites, and the computerized medical record with interlocked laboratory, radiology, demographics, appointments and on-line digital images. Recruiting participants onto prevention trials has been helped by direct recruiting by Geisinger's HMO, which is clinical research friendly, seeing such activities as part of its primary health promotion mission. This proposal retains NCCTG as the primary research base, ECOG as a secondary base, COG as our children's base, and GOG (MD Anderson affiliation) as a separate gynecologic base.
Related Clinical Trials Conducted by the group:
| 1 | Clinical Significance of Genetic Markers in Colorectal Cancer | |
| 2 | Diagnostic Study to Correlate Histopathology, Immunochemistry, and Quantitative Radiology With Outcome in Patients With Early Stage Nonseminomatous Germ Cell Tumor of the Testis | |
| 3 | Genetic Mapping of Interactive Susceptibility Loci in Patients and Siblings with Breast, Colon, Lung, or Prostate Cancer | |
| 4 | Phase I Study of Aerosolized Sargramostim (GM-CSF) in Patients With Metastatic Melanoma to the Lung | |
| 5 | Phase I Study of Amifostine and High-Dose Melphalan in Patients With Primary Systemic Amyloidosis Undergoing Autologous Peripheral Blood Stem Cell Transplantation | |
| 6 | Phase I/II Pilot Study of Adjuvant Irinotecan and Radiotherapy Followed By Irinotecan and Carmustine in Patients With Glioblastoma Multiforme | |
| 7 | Phase I/II Study of Carboplatin and Paclitaxel in Combination With Radiotherapy in Patients With Unresectable Non-Small Cell Lung Cancer | |
| 8 | Phase I/II Study of Erlotinib, Temozolomide, and Radiotherapy in Patients With Glioblastoma Multiforme or Other Brain Tumors | |
| 9 | Phase I/II Study of Gemcitabine and Pemetrexed Disodium in Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer | |
| 10 | Phase II Neoadjuvant Study of Radiotherapy Concurrently With Paclitaxel, Carboplatin, and Fluorouracil Before Esophagectomy in Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction | |
| 11 | Phase II Pilot Study of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia | |
| 12 | Phase II Randomized Study of Anastrozole and Gefitinib Versus Fulvestrant and Gefitinib in Postmenopausal Women With Recurrent or Metastatic Hormone Receptor-Positive Breast Cancer | |
| 13 | Phase II Randomized Study of BAY 43-9006 in Patients With Refractory Non-Small Cell Lung Cancer | |
| 14 | Phase II Randomized Study of Gemcitabine and Radiotherapy Versus Gemcitabine, Fluorouracil, and Cisplatin Followed By Radiotherapy and Fluorouracil in Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the Pancreas | |
| 15 | Phase II Randomized Study of Irinotecan and Docetaxel With or Without Cetuximab in Patients With Metastatic Adenocarcinoma of the Pancreas | |
| 16 | Phase II Randomized Study of Multi-Epitope Vaccination With Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Patients With Metastatic Melanoma | |
| 17 | Phase II Randomized Study of Radiotherapy With Pre- and Post-Operative Cisplatin Plus Paclitaxel Versus Cisplatin Plus Irinotecan in Patients With Operable Adenocarcinoma of the Esophagus or Gastroesophageal Junction | |
| 18 | Phase II Randomized Study of Topotecan, Cisplatin, and Etoposide and Irinotecan, Cisplatin, and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer | |
| 19 | Phase II Study of Bortezomib in Patients With Hepatocellular Carcinoma | |
| 20 | Phase II Study of Rituximab and CHOP Chemotherapy Comprising Prednisone, Cyclophosphamide, Doxorubicin, and Vincristine Followed By Yttrium Y 90 Ibritumomab Tiuxetan (Yttrium Y 90 Zevalin??A?) in Patients With Previously Untreated Mantle Cell Lymphoma | |
| 21 | Phase II Study of 3-AP (Triapine) and Gemcitabine as Second-Line Treatment in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer | |
| 22 | Phase II Study of Adjuvant Radiotherapy After Resection in Patients With Desmoplastic Melanoma | |
| 23 | Phase II Study of Alemtuzumab (Monoclonal Antibody CD52; Campath-1H) and Peripheral Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia | |
| 24 | Phase II Study of Amifostine and High-Dose Melphalan Followed By Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma | |
| 25 | Phase II Study of Atrasentan in Patients With Locally Recurrent or Metastatic Renal Cell Carcinoma | |
| 26 | Phase II Study of Bortezomib Followed By the Addition of Doxorubicin at Disease Progression in Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma of the Head and Neck | |
| 27 | Phase II Study of Bortezomib in Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma | |
| 28 | Phase II Study of CCI-779 in Patients With Previously Treated Mantle Cell Non-Hodgkin's Lymphoma | |
| 29 | Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme | |
| 30 | Phase II Study of CCI-779 in Patients With Stage IIIB (With Pleural Effusion) or IV Non-Small Cell Lung Cancer | |
| 31 | Phase II Study of Capecitabine and Tipifarnib in Women With Taxane-Resistant Metastatic Breast Cancer | |
| 32 | Phase II Study of Carboplatin and Paclitaxel in Patients With Advanced Thymoma or Thymic Carcinoma | |
| 33 | Phase II Study of Chemoembolization in Patients with Unresectable Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases | |
| 34 | Phase II Study of Cisplatin, Etoposide, and Bevacizumab in Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer | |
| 35 | Phase II Study of Cyclosporine in Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma | |
| 36 | Phase II Study of Dalteparin and Conventional Radiotherapy in Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme | |
| 37 | Phase II Study of Docetaxel and Capecitabine in Patients With Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction | |
| 38 | Phase II Study of Docetaxel, Capecitabine, and Bevacizumab as First-Line Chemotherapy in Patients With Metastatic Breast Cancer | |
| 39 | Phase II Study of Doxorubicin HCl Liposome and Docetaxel With or Without Trastuzumab (Herceptin??A?A?) in Women With Metastatic Breast Cancer | |
| 40 | Phase II Study of Doxorubicin and Gemcitabine in Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Cancer With Sarcomatoid Features | |
| 41 | Phase II Study of Gefitinib Alone or With Carboplatin and Paclitaxel in Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer | |
| 42 | Phase II Study of Gefitinib in Patients With Advanced Unresectable Hepatocellular Carcinoma | |
| 43 | Phase II Study of Gemcitabine and Epirubicin in Patients With Malignant Pleural Mesothelioma | |
| 44 | Phase II Study of Gemcitabine and Irinotecan in Patients With Carcinoma of Unknown Primary | |
| 45 | Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone Followed By Systemic Therapy With Oxaliplatin and Capecitabine in Patients With Surgically Resected Liver Metastases from Primary Colorectal Carcinoma | |
| 46 | Phase II Study of High-Dose Methotrexate and Leucovorin Calcium Followed By Radiotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme | |
| 47 | Phase II Study of Imatinib Mesylate in Patients With Recurrent Oligodendroglioma or Mixed Oligoastrocytoma | |
| 48 | Phase II Study of Induction Chemoradiotherapy Comprising Cisplatin and Etoposide Followed by Surgical Resection and Adjuvant Docetaxel in Patients With Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors) | |
| 49 | Phase II Study of Interferon alfa, Isotretinoin, and Paclitaxel in Patients With Recurrent Small Cell Lung Cancer | |
| 50 | Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Locally Recurrent Head and Neck Cancer | |
| 51 | Phase II Study of Irinotecan and Docetaxel in Patients With Refractory Metastatic Breast Cancer | |
| 52 | Phase II Study of Irinotecan, Fluorouracil, Leucovorin Calcium, and Oxaliplatin as First-Line Treatment for Patients With Advanced Small Bowel Adenocarcinoma | |
| 53 | Phase II Study of Irinotecan, Fluorouracil, Leucovorin Calcium, and Oxaliplatin as First-Line Treatment in Patients With Metastatic Colorectal Cancer | |
| 54 | Phase II Study of Ixabepilone in Patients With Metastatic Hormone-Refractory Adenocarcinoma of the Prostate | |
| 55 | Phase II Study of Ixabepilone in Patients With Advanced Carcinoma of the Urothelium | |
| 56 | Phase II Study of Low-Dose PEG-Interferon alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor | |
| 57 | Phase II Study of Lycopene in Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer Who Have an Elevated Prostate-Specific Antigen Level | |
| 58 | Phase II Study of Methotrexate With or Without Cyclophosphamide in Patients with Large Granular Lymphocytic Leukemia | |
| 59 | Phase II Study of Minimally Invasive Esophagectomy in Patients With High-Grade Dysplasia of the Esophagus or Stage I-III Esophageal Cancer | |
| 60 | Phase II Study of Neoadjuvant Celecoxib and Capecitabine in Combination With Pelvic Irradiation in Patients With Stage II or III Adenocarcinoma of the Rectum | |
| 61 | Phase II Study of Neoadjuvant Erlotinib in Patients With Early-Stage Operable Non-Small Cell Lung Cancer | |
| 62 | Phase II Study of Neoadjuvant Induction Therapy Comprising Cetuximab, Paclitaxel, and Carboplatin Followed By Chemoradiotherapy Comprising Cetuximab, Paclitaxel, Carboplatin, and Radiotherapy in Patients With Stage III or IV Operable Squamous Cell Cancer of the Head and Neck | |
| 63 | Phase II Study of Oxaliplatin, Fluorouracil, Leucovorin Calcium, and Cetuximab in Patients With Unresectable Hepatic Metastases Secondary to Metastatic Colorectal Adenocarcinoma | |
| 64 | Phase II Study of Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Collecting Duct Renal Cell Cancer | |
| 65 | Phase II Study of Pemetrexed Disodium and Gemcitabine in Patients With Advanced Cancer of the Urothelium | |
| 66 | Phase II Study of Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia | |
| 67 | Phase II Study of Perifosine in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer | |
| 68 | Phase II Study of Preradiation Combination Chemotherapy in Adults with Poor-Risk Medulloblastoma, Peripheral Primitive Neuroectodermal Tumor, or Disseminated Ependymoma | |
| 69 | Phase II Study of Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, and Vincristine Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Stage I or II CD20-Positive Diffuse Large Cell Lymphoma | |
| 70 | Phase II Study of Salvage Cellular Immunotherapy With Donor Lymphocyte Infusions in Patients With Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation from an HLA-Matched Sibling Donor | |
| 71 | Phase II Study of Temozolomide and Radiotherapy in Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Disease Involving the Central Nervous System | |
| 72 | Phase II Study of Temozolomide and Whole Brain Radiotherapy in Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer | |
| 73 | Phase II Study of Topotecan and Paclitaxel Before and After High-Dose Thoracic Radiotherapy With Concurrent Cisplatin, Etoposide, and Amifostine in Patients With Limited Stage Small Cell Lung Cancer (Phase I closed to accrual as of 5/29/2004) | |
| 74 | Phase II Study of Trastuzumab (Herceptin??A?), Ixabepilone, and Carboplatin in Patients With HER2/neu-Positive Metastatic Breast Cancer | |
| 75 | Phase II Study of a Nonmyeloablative Conditioning Regimen Followed By Allogeneic Bone Marrow Transplantation in Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma | |
| 76 | Phase II Study of a Reduced-Intensity Preparative Regimen With Allogeneic Bone Marrow Transplantation in Patients With Myelodysplastic Syndromes | |
| 77 | Phase III Randomized Adjuvant Study of High-Dose Interferon alfa-2b Therapy in Patients With Stage II or III Melanoma | |
| 78 | Phase III Randomized Chemoprevention Study of Selenium in Participants With Previously Resected Stage I Non-Small Cell Lung Cancer | |
| 79 | Phase III Randomized Study of Adjuvant Irinotecan Versus Oxaliplatin With Fluorouracil and Leucovorin Calcium Versus Both Regimens Administered Consecutively With Versus Without Cetuximab in Patients With Curatively Resected Stage III Colon Cancer | |
| 80 | Phase III Randomized Study of (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy | |
| 81 | Phase III Randomized Study of Adjuvant Irinotecan, Fluorouracil, and Leucovorin Calcium Versus Oxaliplatin, Fluorouracil, and Leucovorin Calcium Versus Fluorouracil and Leucovorin Calcium in Patients With Stage II or III Rectal Cancer Receiving Combined Radiotherapy and Fluorouracil Either Preoperatively or Postoperatively | |
| 82 | Phase III Randomized Study of Adjuvant Isotretinoin, Interferon alfa, and Vitamin E in Patients With Stage III or IV Squamous Cell Carcinoma of the Head and Neck | |
| 83 | Phase III Randomized Study of Allogeneic or Autologous Stem Cell Transplantation Versus Conventional Consolidation and Maintenance Chemotherapy in Patients With Acute Lymphoblastic Leukemia in First Remission | |
| 84 | Phase III Randomized Study of Calcium and Cholecalciferol With or Without Conjugated Estrogens and With or Without Risedronate for the Prevention of Osteoporosis in Patients With Prostate Cancer Receiving Androgen-Ablation Therapy | |
| 85 | Phase III Randomized Study of Carboplatin, Paclitaxel, and Chemoradiotherapy With or Without Thalidomide in Patients With Stage III Non-Small Cell Lung Cancer | |
| 86 | Phase III Randomized Study of Creatine in Patients With Cancer-Associated Weight Loss | |
| 87 | Phase III Randomized Study of Daunorubicin and Cytarabine With or Without Gemtuzumab Ozogamicin Followed By Autologous Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia | |
| 88 | Phase III Randomized Study of Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts (RAEB) in Transformation, or High-Risk RAEB | |
| 89 | Phase III Randomized Study of Docetaxel With or Without Gefitinib in Patients With Metastatic or Locally Recurrent Squamous Cell Carcinoma of the Head and Neck | |
| 90 | Phase III Randomized Study of Docetaxel With or Without Infliximab in Elderly or Poor Performance Status Patients With Wasting, Anorexia, and Asthenia Related to Unresectable Non-Small Cell Lung Cancer | |
| 91 | Phase III Randomized Study of Doxorubicin Plus Cyclophosphamide Followed By Paclitaxel With or Without Trastuzumab (Herceptin) in Women With HER-2-Overexpressing Node-Positive or High-Risk Node-Negative Breast Cancer | |
| 92 | Phase III Randomized Study of Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) Versus Doxorubicin, Vinblastine, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone (Stanford V) With or Without Radiotherapy in Patients With Locally Extensive or Advanced Hodgkin's Lymphoma | |
| 93 | Phase III Randomized Study of Epoetin alfa With or Without Dexamethasone for the Treatment of Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer | |
| 94 | Phase III Randomized Study of Etanercept for the Treatment of Cancer-Related Cachexia and Anorexia in Patients With Advanced Malignancies | |
| 95 | Phase III Randomized Study of Gabapentin With Versus Without Antidepressants for the Management of Hot Flashes in Women With a History of Breast Cancer or a Concern About Taking Hormonal Therapy Due to a Fear of Developing Breast Cancer | |
| 96 | Phase III Randomized Study of Gabapentin for the Management of Hot Flashes in Patients With Prostate Cancer | |
| 97 | Phase III Randomized Study of Gemcitabine With or Without Radiotherapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer | |
| 98 | Phase III Randomized Study of Interferon alfa-2b With or Without Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma | |
| 99 | Phase III Randomized Study of Lamotrigine for Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer | |
| 100 | Phase III Randomized Study of Lidocaine Patch in Cancer Patients With Postsurgical Neuropathic Pain | |
| 101 | Phase III Randomized Study of Low-Dose Testosterone to Enhance Libido in Postmenopausal Female Cancer Survivors | |
| 102 | Phase III Randomized Study of Medroxyprogesterone Versus Venlafaxine in Women With Symptomatic Hot Flashes | |
| 103 | Phase III Randomized Study of Octreotide For Prevention of Acute Diarrhea in Patients Receiving Radiotherapy to the Pelvis | |
| 104 | Phase III Randomized Study of Prolonged Infusion Gemcitabine With Versus Without Oxaliplatin Versus Standard Infusion Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer | |
| 105 | Phase III Randomized Study of Risedronate For Prevention of Bone Loss in Premenopausal Women Undergoing Chemotherapy For Primary Breast Cancer | |
| 106 | Phase III Randomized Study of Rituximab in Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma | |
| 107 | Phase III Randomized Study of Sargramostim (GM-CSF) and Peptide Vaccination Comprised of Tyrosinase:368-376, gp100:209-217 (210M) Antigen, and MART-1:27-35 Peptide Versus Peptide Vaccination Alone Versus GM-CSF Alone Versus Placebo in Patients With Locally Advanced or Metastatic Melanoma | |
| 108 | Phase III Randomized Study of Second-Line Hormonal Therapy (Ketoconazole and Hydrocortisone) Versus Combination Chemotherapy (Docetaxel and Estramustine) in Asymptomatic Patients With Prostate Cancer and a Rising Prostate-Specific Antigen After Androgen Suppression | |
| 109 | Phase III Randomized Study of Zinc Sulfate for the Prevention of Altered Taste in Patients With Head and Neck Cancer Undergoing Radiotherapy | |
| 110 | Pilot Study of Erlotinib in Patients With Stage IIIB or IV or Recurrent Non-Small Cell Lung Cancer | |
| 111 | Randomized Pilot Study to Evaluate Educational Intervention and Behavioral Skills Training for Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer | |
| 112 | Randomized Study of EGb761 for the Prevention of Chemotherapy-Related Cognitive Dysfunction in Women With Breast Cancer | |
This project is coded as follows:
Type of Cancer Research Codes:
- Education and Communication
- Resources and Infrastructure Related to Cancer Control, Survivorship, and Outcomes Research
Type of Cancer Codes:
- Bladder Cancer
- Blood Cancer
- Bone Cancer, Osteosarcoma/Malignant Fibrous Histiocytoma
- Bone Marrow Transplantation
- Brain Tumor
- Breast Cancer
- Cervical Cancer
- Colon and Rectal Cancer
- Esophageal Cancer
- Gastrointestinal Tract
- Genital System, Female
- Genital System, Male
- Head and Neck Cancer
- Hodgkin's Disease
- Kidney Cancer
- Leukemia
- Liver Cancer
- Lung Cancer
- Melanoma
- Myeloma
- Nervous System
- Neuroblastoma
- Non-Hodgkin's Lymphoma
- Pancreatic Cancer
- Prostate Cancer
- Respiratory System
- Sarcoma, Rhabdomyosarcoma, Childhood
- Sarcoma, Soft Tissue
- Skin Cancer
- Thymoma, Malignant
- Urinary System
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