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Alliance for Clinical Trials in Oncology

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https://www.readbyqxmd.com/read/28199818/cabozantinib-versus-sunitinib-as-initial-targeted-therapy-for-patients-with-metastatic-renal-cell-carcinoma-of-poor-or-intermediate-risk-the-alliance-a031203-cabosun-trial
#1
Toni K Choueiri, Susan Halabi, Ben L Sanford, Olwen Hahn, M Dror Michaelson, Meghara K Walsh, Darren R Feldman, Thomas Olencki, Joel Picus, Eric J Small, Shaker Dakhil, Daniel J George, Michael J Morris
Purpose Cabozantinib is an oral potent inhibitor of vascular endothelial growth factor receptor 2, MET, and AXL and is a standard second-line therapy for metastatic renal cell carcinoma (mRCC). This randomized phase II multicenter trial evaluated cabozantinib compared with sunitinib as first-line therapy in patients with mRCC. Patients and Methods Eligible patients had untreated clear cell mRCC and Eastern Cooperative Oncology Group performance status of 0 to 2 and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria...
February 20, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152764/initiative-to-streamline-clinical-trials-isct-guidance-for-academic-investigators-sponsors
#2
Katherine Brodeur-Robb, Alison May Urton, Jacqueline Bosch, Lesley Seymour, Karen E Arts
: 219 Background: The 2011 Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials in Canada outlined in detail the threats to the conduct of academic oncology clinical trials caused by increasing complexity and workload resulting from a perceived onerous regulatory environment. The report recommended engaging Health Canada and key stakeholders to foster agreement in appropriate interpretations of the Canadian Food and Drug Regulations Part C Division 5 and ICH Good Clinical Practice (GCP) guidelines...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28095882/the-use-of-dose-escalated-radiation-for-locally-advanced-non-small-cell-lung-cancer-in-the-u-s-2004-2013
#3
John P Christodouleas, Matthew D Hall, Marjorie A van der Pas, Wensheng Guo, Timothy E Schultheiss, Peter Gabriel
PURPOSE/OBJECTIVES: The clinical effects of radiation dose-intensification in locally advanced non-small cell lung (NSCLCa) and other cancers are challenging to predict and are ideally studied in randomized trials. The purpose of this study was to assess the use of dose-escalated radiation for locally advanced NSCLCa in the U.S., 2004-2013, a period in which there were no published level 1 studies on dose-escalation. MATERIALS/METHODS: We performed analyses on two cancer registry databases with complementary strengths and weaknesses: the National Oncology Data Alliance (NODA) 2004-2013 and the National Cancer Database (NCDB) 2004-2012...
January 17, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28045625/ki67-proliferation-index-as-a-tool-for-chemotherapy-decisions-during-and-after-neoadjuvant-aromatase-inhibitor-treatment-of-breast-cancer-results-from-the-american-college-of-surgeons-oncology-group-z1031-trial-alliance
#4
Matthew J Ellis, Vera J Suman, Jeremy Hoog, Rodrigo Goncalves, Souzan Sanati, Chad J Creighton, Katherine DeSchryver, Erika Crouch, Amy Brink, Mark Watson, Jingqin Luo, Yu Tao, Michael Barnes, Mitchell Dowsett, G Thomas Budd, Eric Winer, Paula Silverman, Laura Esserman, Lisa Carey, Cynthia X Ma, Gary Unzeitig, Timothy Pluard, Pat Whitworth, Gildy Babiera, J Michael Guenther, Zoneddy Dayao, David Ota, Marilyn Leitch, John A Olson, D Craig Allred, Kelly Hunt
Purpose To determine the pathologic complete response (pCR) rate in estrogen receptor (ER) -positive primary breast cancer triaged to chemotherapy when the protein encoded by the MKI67 gene (Ki67) level was > 10% after 2 to 4 weeks of neoadjuvant aromatase inhibitor (AI) therapy. A second objective was to examine risk of relapse using the Ki67-based Preoperative Endocrine Prognostic Index (PEPI). Methods The American College of Surgeons Oncology Group (ACOSOG) Z1031A trial enrolled postmenopausal women with stage II or III ER-positive (Allred score, 6 to 8) breast cancer whose treatment was randomly assigned to neoadjuvant AI therapy with anastrozole, exemestane, or letrozole...
January 3, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27992272/accrual-of-older-patients-with-breast-cancer-to-alliance-systemic-therapy-trials-over-time-protocol-a151527
#5
Rachel A Freedman, Jared C Foster, Drew K Seisler, Jacqueline M Lafky, Hyman B Muss, Harvey J Cohen, Jeanne Mandelblatt, Eric P Winer, Clifford A Hudis, Ann H Partridge, Lisa A Carey, Constance Cirrincione, Alvaro Moreno-Aspitia, Gretchen Kimmick, Aminah Jatoi, Arti Hurria
Purpose Despite increasing awareness of accrual challenges, it is unknown if accrual of older patients to breast cancer treatment trials is improving. Methods We examined accrual of older patients to Alliance for Clinical Trials in Oncology systemic therapy breast cancer trials during 1985-2012 and compared disease characteristics and reasons for therapy cessation for older (age ≥ 65 years and ≥ 70 years) versus younger (age < 65 years and < 70 years) participants. To examine accrual trends, we modeled age as a function of time, using logistic regression...
February 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27866278/risk-of-acute-myeloid-leukemia-and-myelodysplastic-syndrome-among-older-women-receiving-anthracycline-based-adjuvant-chemotherapy-for-breast-cancer-on-modern-cooperative-group-trials-alliance-a151511
#6
Rachel A Freedman, D K Seisler, J C Foster, J A Sloan, J M Lafky, G G Kimmick, A Hurria, H J Cohen, E P Winer, C A Hudis, A H Partridge, L A Carey, A Jatoi, H D Klepin, M Citron, D A Berry, L N Shulman, A U Buzdar, V J Suman, H B Muss
PURPOSE: We examined acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) events among 9679 women treated for breast cancer on four adjuvant Alliance for Clinical Trials in Oncology trials with >90 months of follow-up in order to better characterize the risk for AML/MDS in older patients receiving anthracyclines. METHODS: We used multivariable Cox regression to examine factors associated with AML/MDS, adjusting for age (≥65 vs. <65 years; separately for ≥70 vs...
January 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/27704226/impact-of-neoadjuvant-therapy-on-eligibility-for-and-frequency-of-breast-conservation-in-stage-ii-iii-her2-positive-breast-cancer-surgical-results-of-calgb-40601-alliance
#7
Mehra Golshan, Constance T Cirrincione, William M Sikov, Lisa A Carey, Donald A Berry, Beth Overmoyer, Nora L Henry, George Somlo, Elisa Port, Harold J Burstein, Clifford Hudis, Eric Winer, David W Ollila
OBJECTIVE: It had been previously shown that patients who receive neoadjuvant systemic therapy (NST) are more likely to undergo breast-conserving therapy (BCT) than those who have primary surgery. However, the frequency with which patients who are not BCT-eligible prior to NST convert to BCT-eligible with treatment is unknown. To document this conversion rate in a subset of patients expected to have a high clinical response rate to NST, we studied surgical assessment and management of patients enrolled on a randomized neoadjuvant trial for stage II-III HER2-positive breast cancer (HER2 + BC)(CALGB 40601)...
November 2016: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/27697771/phase-1-trial-of-rituximab-lenalidomide-and-ibrutinib-in-previously-untreated-follicular-lymphoma-alliance-a051103
#8
Chaitra S Ujjani, Sin-Ho Jung, Brandelyn Pitcher, Peter Martin, Steven I Park, Kristie A Blum, Sonali M Smith, Myron Czuczman, Matthew S Davids, Ellis Levine, Lionel D Lewis, Scott E Smith, Nancy L Bartlett, John P Leonard, Bruce D Cheson
Chemoimmunotherapy in follicular lymphoma is associated with significant toxicity. Targeted therapies are being investigated as potentially more efficacious and tolerable alternatives for this multiply-relapsing disease. Based on promising activity with rituximab and lenalidomide in previously untreated follicular lymphoma (overall response rate [ORR] 90%-96%) and ibrutinib in relapsed disease (ORR 30%-55%), the Alliance for Clinical Trials in Oncology conducted a phase 1 trial of rituximab, lenalidomide, and ibrutinib...
November 24, 2016: Blood
https://www.readbyqxmd.com/read/27502708/phase-ii-study-of-mln8237-alisertib-in-advanced-metastatic-sarcoma
#9
M A Dickson, M R Mahoney, W D Tap, S P D'Angelo, M L Keohan, B A Van Tine, M Agulnik, L E Horvath, J S Nair, G K Schwartz
BACKGROUND: Aurora kinase A (AURKA) is commonly overexpressed in sarcoma. The inhibition of AURKA by shRNA or by a specific AURKA inhibitor blocks in vitro proliferation of multiple sarcoma subtypes. MLN8237 (alisertib) is a novel oral adenosine triphosphate-competitive AURKA inhibitor. PATIENTS AND METHODS: This Cancer Therapy Evaluation Program-sponsored phase II study of alisertib was conducted through the Alliance for Clinical Trials in Oncology (A091102). Patients were enrolled into histology-defined cohorts: (i) liposarcoma, (ii) leiomyosarcoma, (iii) undifferentiated sarcoma, (iv) malignant peripheral nerve sheath tumor, or (v) other...
October 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/27465221/blood-based-markers-of-efficacy-and-resistance-to-cetuximab-treatment-in-metastatic-colorectal-cancer-results-from-calgb-80203-alliance
#10
Ace J Hatch, Alexander B Sibley, Mark D Starr, J Chris Brady, Chen Jiang, Jingquan Jia, Daniel L Bowers, Herbert Pang, Kouros Owzar, Donna Niedzwiecki, Federico Innocenti, Alan P Venook, Herbert I Hurwitz, Andrew B Nixon
Circulating protein markers were assessed in patients with colorectal cancer (CRC) treated with cetuximab in CALGB 80203 to identify prognostic and predictive biomarkers. Patients with locally advanced or metastatic CRC received FOLFOX or FOLFIRI chemotherapy (chemo) or chemo in combination with cetuximab. Baseline plasma samples from 152 patients were analyzed for six candidate markers [epidermal growth factor (EGF), heparin-binding EGF (HBEGF), epidermal growth factor receptor (EGFR), HER2, HER3, and CD73]...
September 2016: Cancer Medicine
https://www.readbyqxmd.com/read/27365012/patient-reported-outcomes-questionnaire-compliance-in-cancer-cooperative-group-trials-alliance-n0992
#11
Pamela J Atherton, Kelli N Burger, Levi D Pederson, Suneetha Kaggal, Jeff A Sloan
BACKGROUND/AIMS: The use of patient-reported outcomes in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing patient-reported outcomes. METHODS: Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27354129/n08c9-alliance-a-phase-3-randomized-study-of-sulfasalazine-versus-placebo-in-the-prevention-of-acute-diarrhea-in-patients-receiving-pelvic-radiation-therapy
#12
Robert C Miller, Daniel G Petereit, Jeff A Sloan, Heshan Liu, James A Martenson, James D Bearden, Ronald Sapiente, Grant R Seeger, Rex B Mowat, Ben Liem, Matthew J Iott, Charles L Loprinzi
PURPOSE: To provide confirmatory evidence on the use of sulfasalazine to reduce enteritis during pelvic radiation therapy (RT), following 2 prior single-institution trials suggestive that benefit existed. METHODS AND MATERIALS: A multi-institution, randomized, double-blind, placebo-controlled phase 3 trial was designed to assess the efficacy of sulfasalazine versus placebo in the treatment of RT-related enteritis during RT including the posterior pelvis (45.0-53...
July 15, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/27275632/preoperative-modified-folfirinox-treatment-followed-by-capecitabine-based-chemoradiation-for-borderline-resectable-pancreatic-cancer-alliance-for-clinical-trials-in-oncology-trial-a021101
#13
Matthew H G Katz, Qian Shi, Syed A Ahmad, Joseph M Herman, Robert de W Marsh, Eric Collisson, Lawrence Schwartz, Wendy Frankel, Robert Martin, William Conway, Mark Truty, Hedy Kindler, Andrew M Lowy, Tanios Bekaii-Saab, Philip Philip, Mark Talamonti, Dana Cardin, Noelle LoConte, Perry Shen, John P Hoffman, Alan P Venook
IMPORTANCE: Although consensus statements support the preoperative treatment of borderline resectable pancreatic cancer, no prospective, quality-controlled, multicenter studies of this strategy have been conducted. Existing studies are retrospective and confounded by heterogeneity in patients studied, therapeutic algorithms used, and outcomes reported. OBJECTIVE: To determine the feasibility of conducting studies of multimodality therapy for borderline resectable pancreatic cancer in the cooperative group setting...
August 17, 2016: JAMA Surgery
https://www.readbyqxmd.com/read/27197192/improved-survival-of-her2-breast-cancer-patients-treated-with-trastuzumab-and-chemotherapy-is-associated-with-host-antibody-immunity-against-the-her2-intracellular-domain
#14
Keith L Knutson, Raphael Clynes, Barath Shreeder, Patrick Yeramian, Kathleen P Kemp, Karla Ballman, Kathleen S Tenner, Courtney L Erskine, Nadine Norton, Donald Northfelt, Winston Tan, Carmen Calfa, Mark Pegram, Elizabeth A Mittendorf, Edith A Perez
The addition of trastuzumab to chemotherapy extends survival among patients with HER2(+) breast cancer. Prior work showed that trastuzumab and chemotherapy augments HER2 extracellular domain (ECD)-specific antibodies. The current study investigated whether combination therapy induced immune responses beyond HER2-ECD and, importantly, whether those immune responses were associated with survival. Pretreatment and posttreatment sera were obtained from 48 women with metastatic HER2(+) breast cancer on NCCTG (now Alliance for Clinical Trials in Oncology) studies, N0337 and N983252...
July 1, 2016: Cancer Research
https://www.readbyqxmd.com/read/27083333/longitudinal-adverse-event-assessment-in-oncology-clinical-trials-the-toxicity-over-time-toxt-analysis-of-alliance-trials-ncctg-n9741-and-979254
#15
Gita Thanarajasingam, Pamela J Atherton, Paul J Novotny, Charles L Loprinzi, Jeff A Sloan, Axel Grothey
BACKGROUND: Traditional methods of reporting adverse events in clinical trials are inadequate for modern cancer treatments with chronic administration. Conventional analysis and display of maximum grade adverse events do not capture toxicity profiles that evolve over time or longer lasting, lower grade toxic effects; we aimed to address this shortcoming in this study. METHODS: We developed an analytic approach and standardised, comprehensive format, the Toxicity over Time (ToxT) approach, which combines graphs and adverse event tabular displays with multiple longitudinal statistical techniques into a readily applicable method to study toxic effects...
May 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27069074/us-intergroup-trial-of-response-adapted-therapy-for-stage-iii-to-iv-hodgkin-lymphoma-using-early-interim-fluorodeoxyglucose-positron-emission-tomography-imaging-southwest-oncology-group-s0816
#16
Oliver W Press, Hongli Li, Heiko Schöder, David J Straus, Craig H Moskowitz, Michael LeBlanc, Lisa M Rimsza, Nancy L Bartlett, Andrew M Evens, Erik S Mittra, Ann S LaCasce, John W Sweetenham, Paul M Barr, Michelle A Fanale, Michael V Knopp, Ariela Noy, Eric D Hsi, James R Cook, Mary Jo Lechowicz, Randy D Gascoyne, John P Leonard, Brad S Kahl, Bruce D Cheson, Richard I Fisher, Jonathan W Friedberg
PURPOSE: Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. PATIENTS AND METHODS: The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012...
June 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27060850/alcohol-consumption-and-colon-cancer-prognosis-among-participants-in-north-central-cancer-treatment-group-phase-iii-trial-n0147
#17
Amanda I Phipps, Qian Shi, Paul J Limburg, Garth D Nelson, Daniel J Sargent, Frank A Sinicrope, Emily Chan, Sharlene Gill, Richard M Goldberg, Morton Kahlenberg, Suresh Nair, Anthony F Shields, Polly A Newcomb, Steven R Alberts
Alcohol consumption is associated with a modest increased risk of colon cancer, but its relationship with colon cancer survival has not been elucidated. Using data from a phase III randomized adjuvant trial, we assessed the association of alcohol consumption with colon cancer outcomes. Patients completed a risk factor questionnaire before randomization to FOLFOX or FOLFOX + cetuximab (N = 1984). Information was collected on lifestyle factors, including smoking, physical activity and consumption of different types of alcohol...
September 1, 2016: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/26870806/a-molecular-model-for-predicting-overall-survival-in-patients-with-metastatic-clear-cell-renal-carcinoma-results-from-calgb-90206-alliance
#18
Hyung L Kim, Susan Halabi, Ping Li, Greg Mayhew, Jeff Simko, Andrew B Nixon, Eric J Small, Brian Rini, Michael J Morris, Mary-Ellen Taplin, Daniel George
BACKGROUND: Prognosis associated with metastatic renal cell carcinoma (mRCC) can vary widely. METHODS: This study used pretreatment nephrectomy specimens from a randomized phase III trial. Expression levels of candidate genes were determined from archival tumors using the OpenArray® platform for TaqMan® RT-qPCR. The dataset was randomly divided at 2:1 ratio into training (n = 221) and testing (n = 103) sets to develop a multigene prognostic signature. FINDINGS: Gene expressions were measured in 324 patients...
November 2015: EBioMedicine
https://www.readbyqxmd.com/read/26867878/patterns-of-local-regional-management-following-neoadjuvant-chemotherapy-in-breast-cancer-results-from-acosog-z1071-alliance
#19
MULTICENTER STUDY
Bruce G Haffty, Linda M McCall, Karla V Ballman, Sarah McLaughlin, Reshma Jagsi, David W Ollila, Kelly K Hunt, Thomas A Buchholz, Judy C Boughey
PURPOSE: American College of Surgeons Oncology Group Z1071 was a prospective trial evaluating the false negative rate of sentinel lymph node (SLN) surgery after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial node-positive disease. Radiation therapy (RT) decisions were made at the discretion of treating physicians, providing an opportunity to evaluate variability in practice patterns following NAC. METHODS AND MATERIALS: Of 756 patients enrolled from July 2009 to June 2011, 685 met all eligibility requirements...
March 1, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/26649589/identification-and-resection-of-clipped-node-decreases-the-false-negative-rate-of-sentinel-lymph-node-surgery-in-patients-presenting-with-node-positive-breast-cancer-t0-t4-n1-n2-who-receive-neoadjuvant-chemotherapy-results-from-acosog-z1071-alliance
#20
MULTICENTER STUDY
Judy C Boughey, Karla V Ballman, Huong T Le-Petross, Linda M McCall, Elizabeth A Mittendorf, Gretchen M Ahrendt, Lee G Wilke, Bret Taback, Eric C Feliberti, Kelly K Hunt
BACKGROUND: The American College of Surgeons Oncology Group Z1071 trial reported a false-negative rate (FNR) of 12.6% with sentinel lymph node (SLN) surgery after neoadjuvant chemotherapy in women presenting with node-positive breast cancer. One proposed method to decrease the FNR is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery. METHODS: Z1071 was a multi-institutional trial wherein women with clinical T0-T4,N1-N2,M0 breast cancer underwent SLN surgery and axillary dissection (ALND) after neoadjuvant chemotherapy...
April 2016: Annals of Surgery
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