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Clinical Trials

Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity
Disease Site: Cancer Control
Protocol Number: WFU 97609
Status: OPEN
Key Eligibility: Newly diagnosed BRCA stage 0-IIIA; plan for adjuvant radiation
Description:
CHANGE IN MAMMOGRAPHIC DENSITY WITH METFORMIN USE: A COMPANION STUDY TO NCIC STUDY MA.32
Disease Site: Cancer Control
Protocol Number: A211201
Status: OPEN
Key Eligibility: Currently or previously enrolled in MA32
Description:
A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer
Disease Site: Breast
Protocol Number: APHINITY (BIG 4-11/BO25126/TOC4939G)
Status: OPEN
Key Eligibility: Non-metastatic primary breast; adequately excised; known hormone receptor status
Description:
Phase I/II Trial of IMC-A12 in Combination with CCI-779 in Patients with Metastatic Breast Cancer
Disease Site: Breast
Protocol Number: 8129
Status: OPEN
Key Eligibility: Metastatic disease or locally recurrent that is stage IV
Description:
Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients with Triple Negative Metastatic Breast Cancer
Disease Site: Breast
Protocol Number: N093B
Status: OPEN
Key Eligibility: Metastatic, unresected, triple negative breast ca; post-menopausal
Description:
NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition (TKI) at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma (RCC)
Disease Site: Genitourinary
Protocol Number: PrE0801
Status: OPEN
Key Eligibility: Recurrent or metastatic renal following adjuvant tx
Description:
A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Disease Site: Breast
Protocol Number: B49
Status: OPEN
Key Eligibility: HER2 Negative; adjuvant
Description:
Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
Disease Site: Cancer Control
Protocol Number: RC11C3
Status: OPEN
Key Eligibility: Adjuvant, weekly paclitaxel, no concurrent therapy
Description:
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
Disease Site: Genitourinary
Protocol Number: R0534
Status: OPEN
Key Eligibility: adenocarcinoma tx'ed primarily w/radical prostatectomy; lympy negative; no prior androgen dep ttx started after prostatectomy orprior to registration
Description:
Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
Disease Site: Cancer Control
Protocol Number: N10C2
Status: OPEN
Key Eligibility: History of br cancer; bothersome hot flashes for more than 30 days; no prior us of Mg for hot flashes
Description:
Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]), Temozolomide, and Radiation Therapy in Patients with Newly Diagnosed Glioblastoma
Disease Site: Brain
Protocol Number: N0874
Status: OPEN
Key Eligibility: Newly diagnosed glioblastoma
Description:
Phase III, Randomized, Study of Sulfasalazine versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Disease Site: Cancer Control
Protocol Number: N08C9
Status: OPEN
Key Eligibility: Subjects receiving pelvic RT; no mets beyond pelvic region, no perineal irradiation or abdominal perineal resection
Description:
Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product (IMC-1121B) versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, or Stomach
Disease Site: Gastrointestinal
Protocol Number: I4T-MC-JVBT
Status: OPEN
Key Eligibility: confirm of adenocarcinoma of esophagus, GEJ, or stomach (adenoquamous eligible); metastatic/locally advanced, unresectable
Description:
Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo-
Disease Site: Cancer Control
Protocol Number: N10C1
Status: OPEN
Key Eligibility: Post-Menopausal; History of breast or gyno cancer - no current disease
Description:
Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined with
Disease Site: Brain
Protocol Number: N0872
Status: OPEN
Key Eligibility: Glioblastoma multiforme (grade 4 astrocytoma)
File: Download
Description:
Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo-
Disease Site: Cancer Control
Protocol Number: N10C1
Status: OPEN
Key Eligibility: Post-Menopausal w/history of breast or gynecologic CA - no current disease; significant vaginal complaints
File: Download
Description:
Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer
Disease Site: Cancer Control
Protocol Number: MA32F
Status: OPEN
Key Eligibility: Consented to MA32 but not yet initiated; current or planned RT
Description:
Randomized Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer
Disease Site: Gastrointestinal
Protocol Number: N0949
Status: OPEN
Key Eligibility: >70 yrs
Description:
The Oncotype DX® Colon Cancer Assay for Stage II Colon Carcinoma: Does it Impact Physician Adjuvant Treatment Decision Making and Patient Satisfaction?
Disease Site: Gastrointestinal
Protocol Number: RC0948
Status: OPEN
Key Eligibility: 15 new colon pts/yr; completely resected stage II w/T3 tumors
Description:
A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-risk Melanoma
Disease Site: Melanoma
Protocol Number: E1609
Status: OPEN
Key Eligibility: Completely resected disease; disease free status; no other malignancies
Description:

INVESTIGATOR TRAINING REQUIRED PRIOR TO ENROLLMENT.  SEE SECTION 4.6.4 OF PROTOCOL

A PHASE III RANDOMIZED TRIAL OF METFORMIN VERSUS PLACEBO ON RECURRENCE AND SURVIVAL IN EARLY STAGE BREAST CANCER
Disease Site: Breast
Protocol Number: MA32
Status: OPEN
Key Eligibility: Invasive breast cancer dx'ed and resected wtihin 12 months prior to randomization. No prior breast cancer.
Description:
A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women with Node-Positive or
Disease Site: Breast
Protocol Number: B46I
Status: OPEN
Key Eligibility: unilateral invasive adenocarcinoma, HER2-negative, no T4, no metastatic disease
Description:
A Phase III Study Evaluating the Role of Perioperative Chemotherapy in Patients with Potentially Resectable Hepatic Colorectal Metastases
Disease Site: Gastrointestinal
Protocol Number: NSABP C11
Status: OPEN
Key Eligibility: Histologic confirmation of colorectal adenocarcinoma, no anal, small bowel, or appendiceal carcinoma or any other colorectal malignant diseases (sarcoma, lymphoma, carcinoid)
Description:
A Randomized Phase III Trial of Adjuvant Therapy Comparing
Disease Site: Breast
Protocol Number: B47
Status: OPEN
Key Eligibility: The tumor must be unilateral invasive adenocarcinoma of the breast on histologic exam; HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low
Description:
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Disease Site: Breast
Protocol Number: E2108
Status: OPEN
Key Eligibility: Patients (male or female) must have an intact primary (not recurrent) invasive
Description:
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
Disease Site: Breast
Protocol Number: CTSU S1007
Status: OPEN
Key Eligibility: ADJUVANT BREAST - Step 1 - hist confirmed dx of node pos(1-3 nodes) invasive br ca w/pos estrogen and/or progesterone receptor status,and neg HER-2; Step 2 - Recurrence score (RS) by Oncotype DX® must be less than or equal to 25
Description:
Randomized Double-Blind Study of Doxepin Rinse versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy with or without Chemotherapy
Disease Site: Cancer Control
Protocol Number: N09C6
Status: OPEN
Key Eligibility: Malignancy undergoing course of RT; 1/3 of oral cavity mucosa must be included in RT fields
Description:
A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB NonSquamous NSCLC after Definitive Chemoradiation
Disease Site: Lung
Protocol Number: E6508
Status: OPEN
Key Eligibility: NSCLC, Nonsquamous, IIIA and IIIB
Description:

No IMRT or 4D RT is allowed on this trial.  The treating RT facility must have an approved 3D RT Benchmark on file with QARC.

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
Disease Site: Hematology
Protocol Number: E3A06
Status: OPEN
Key Eligibility: Assymptomatic, high-risk, smoldering multiple myeloma
Description:
A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab, in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy
Disease Site: Gastrointestinal
Protocol Number: E7208
Status: OPEN
Key Eligibility: Met or adv CRC, KRAS-wild type, first line tx with Oxaliplatin-containing chemo and Avastin. PD within 90 days of last Avastin.
Description:
Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer
Disease Site: Gastrointestinal
Protocol Number: E2208
Status: OPEN
Key Eligibility: Met Esophageal or GE Junction, AEG Type I and II.
Description:
A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen
Disease Site: Breast
Protocol Number: E3108
Status: OPEN
Key Eligibility: Stage III/Stage IV. No prior tx. No prior Tamoxifen
Description:
A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
Disease Site: Gastrointestinal
Protocol Number: C80702
Status: OPEN
Key Eligibility: Resected Stage III Colon
Description:
Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Disease Site: Lung
Protocol Number: E5508
Status: OPEN
Key Eligibility: Advanced NSCLC, Non-Squamous
Description:
Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV NSCLC
Disease Site: Lung
Protocol Number: C30607
Status: OPEN
Key Eligibility: NSCLC, Stage IIIB or IV First Line
Description:
A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab, with or without Everolimus for Therapy of Metastatic Malignant Melanoma
Disease Site: Melanoma
Protocol Number: N0879
Status: OPEN
Key Eligibility: Metastatic Melanoma
Description:
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Disease Site: Breast
Protocol Number: B43
Status: OPEN
Key Eligibility: DCIS HER2 testing by NSABP
Description:
An Intergroup Phase III Randomized Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid™) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy
Disease Site: Hematology
Protocol Number: E1A06
Status: OPEN
Key Eligibility: Newly Diagnosed Multiple Myeloma
Description:
Phase III Double Blind, Placebo Controlled Study of Donepezil in Irradiated Brain Tumor Patients
Disease Site: Cancer Control
Protocol Number: WFU91105
Status: OPEN
Key Eligibility: Aricept/Placebo for Pts Receiving Brain RT
Description:
The Use of Glutathione (GSH) for Prevention of TAXOL/CBDCA Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study
Disease Site: Cancer Control
Protocol Number: N08CA
Status: OPEN
Key Eligibility: Peripheral Neuropathy, Taxol/Carboplatin
Description:
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity
Disease Site: Cancer Control
Protocol Number: N08CB
Status: OPEN
Key Eligibility: Ca/Mg++ or Placebo, Colorectal , FOLFOX
Description:
Paclitaxel-Associated Acute Pain Syndrome Natural History Study
Disease Site: Cancer Control
Protocol Number: N08C1
Status: OPEN
Key Eligibility: Paclitaxel QOL
Description:
A Prospective Observational Multi-Center Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
Disease Site: Cancer Control
Protocol Number: S0702
Status: OPEN
Key Eligibility: Pts Starting Zoledronic Acid / Osteonecrosis of the Jaw
Description:

OMAHA:Use Omaha IC
LINC: Use Lincoln IC
 

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide
Disease Site: Lung
Protocol Number: C30610
Status: OPEN - Omaha sites only
Key Eligibility: SMALL CELL, Limited Stage
Description:

OMAHA:Use Omaha IC
Not avail to Lincoln yet
 

A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab with or without IMC-A12 in Patients with Advanced Non-Squamous, Non-Small Cell Lung Cancer
Disease Site: Lung
Protocol Number: E3508
Status: OPEN
Key Eligibility: Advanced NSCLC
Description:
A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB (>/=+4CM)-IIIA Non-Small Cell Lung Cancer
Disease Site: Lung
Protocol Number: E1505
Status: OPEN
Key Eligibility: NSCLC, Stage IB-IIIA, Completely Resected
Description:
Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
Disease Site: Hematology
Protocol Number: RC0783
Status: OPEN
Key Eligibility: Untreated CLL
Description:
A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
Disease Site: Head/Neck
Protocol Number: E1305
Status: OPEN
Key Eligibility: Recurrent or Metastatic H&N
Description:
Randomized Phase III Trial Comparing the Frequency of Major Erythroid
Disease Site: Hematology
Protocol Number: E2905
Status: OPEN
Key Eligibility: Low- or Intermediate- MDS and Symptomatic Anemia
Description:
A Randomized Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Disease Site: Genitourinary
Protocol Number: C70604
Status: OPEN
Key Eligibility: Metastatic Prostate, Breast, MM
Description:
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
Disease Site: Genitourinary
Protocol Number: C90202
Status: OPEN
Key Eligibility: Metastatic Prostate, Bone Mets
Description:
A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
Disease Site: Genitourinary
Protocol Number: RTOG 0815
Status: OPEN. RT credentialing required
Key Eligibility: Prostate, Intermediate-Risk, RT
Description:

Note: RT site credentialing pending – please check prior to screening/enrollment.

Phase II Trial of Cetuximab Plus Cisplatin, 5-Fluorouracil, and Radiation in Immunocompetent Patients with Anal Carcinoma
Disease Site: Gastrointestinal
Protocol Number: E3205
Status: OPEN
Key Eligibility: Anal
Description:
A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma
Disease Site: Genitourinary
Protocol Number: E4805
Status: OPEN
Key Eligibility: Renal Cell, SECOND LINE, Prior Sutent/Nexavar
Description:
A Double Blind Phase II Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma
Disease Site: Genitourinary
Protocol Number: C90601
Status: OPEN
Key Eligibility: Advanced Bladder, Transitional Cell
Description:
Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
Disease Site: Genitourinary
Protocol Number: C90203
Status: OPEN
Key Eligibility: Prostate, NeoAdjuvant, High-Risk, Clinically Localized
Description:
Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients with Metastatic Colorectal Cancer
Disease Site: Gastrointestinal
Protocol Number: E4203
Status: OPEN
Key Eligibility: Metastatic Colorectal Previously Untreated
Description:
Polyp Prevention Trial in Patients with Resected Colon Cancer
Disease Site: Gastrointestinal
Protocol Number: P5
Status: OPEN
Key Eligibility: Stage I and II colon
Description:
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Disease Site: Gastrointestinal
Protocol Number: R0436
Status: SUSPENDED - RT credentialing pending
Key Eligibility: Esophageal
Description:

Note: RT site credentialing pending – please check prior to screening/enrollment.

Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Disease Site: Carcinoid
Protocol Number: CTSU S0518
Status: OPEN
Key Eligibility: Advanced Carcinoid, Poor Prognosis
Description:
A Randomized Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Disease Site: Breast
Protocol Number: C70604
Status: OPEN
Key Eligibility: Metastatic Breast, No Prior Zometa
Description:
A Randomized, Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound NAB-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Disease Site: Breast
Protocol Number: C40502
Status: OPEN
Key Eligibility: Recurrent or Metastatic Breast FIRST LINE
Description:
Phase III Trial of continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High Risk Node Negative Breast Cancer
Disease Site: Breast
Protocol Number: S0221
Status: OPEN
Key Eligibility: Adjuvant Node Positive or High Risk Node Negative
Description:
A Phase I/II Trial of Sorafenib and CCI-779 in Patients with Recurrent Glioblastoma
Disease Site: Brain
Protocol Number: N0572
Status: OPEN. Arm B temp closed
Key Eligibility: Recurrent Glioblastoma
Description:

Note: RT site credentialing pending - please check prior to screening / enrollment.

Arm B IS CLOSED.  Please note: Study 2, Group 2(Arm C, patients undergoing surgery) and Group 3 (Arm D, patients with prior anti-VEGF treatment and not undergoing surgery) remain open for accrual.

Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma
Disease Site: Brain
Protocol Number: N057K
Status: TEmp Closed eff 1/17/11 - RT credentialing required for IMRT
Key Eligibility: Newly Diagnosed Glioblastoma
Description:

Note: RT facility credentialing required for IMRT

Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases
Disease Site: Brain
Protocol Number: N0574
Status: OPEN
Key Eligibility: 1 to 3 cerebral metastases
Description:

Note: SRS approval at Immanuel location only

Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma
Disease Site: Brain
Protocol Number: N0577
Status: OPEN
Key Eligibility: 1p/19q Co-deleted Anaplastic Glioma
Description:
Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
Disease Site: Brain
Protocol Number: E3F05
Status: OPEN
Key Eligibility: Symptomatic Gliomas
Description:
Missouri Valley Cancer Consortium
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