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Phase 3 oncology

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https://www.readbyqxmd.com/read/27908980/phase-2-study-of-eribulin-in-patients-with-previously-treated-advanced-or-metastatic-soft-tissue-sarcoma
#1
Akira Kawai, Nobuhito Araki, Yoichi Naito, Toshifumi Ozaki, Hideshi Sugiura, Yasuo Yazawa, Hideo Morioka, Akihiko Matsumine, Kenichi Saito, Shun Asami, Kazuo Isu
OBJECTIVE: Eribulin, a microtubule dynamics inhibitor, is approved for the treatment of patients with breast cancer and soft tissue sarcoma. We investigated the efficacy and safety of eribulin in Japanese patients with soft tissue sarcoma. METHODS: This open-label, multicenter, nonrandomized, Phase 2 study enrolled Japanese patients with measurable, advanced/metastatic soft tissue sarcoma of high/intermediate grade and ≥1 prior chemotherapy for advanced disease...
December 1, 2016: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/27908594/rucaparib-in-relapsed-platinum-sensitive-high-grade-ovarian-carcinoma-ariel2-part-1-an-international-multicentre-open-label-phase-2-trial
#2
Elizabeth M Swisher, Kevin K Lin, Amit M Oza, Clare L Scott, Heidi Giordano, James Sun, Gottfried E Konecny, Robert L Coleman, Anna V Tinker, David M O'Malley, Rebecca S Kristeleit, Ling Ma, Katherine M Bell-McGuinn, James D Brenton, Janiel M Cragun, Ana Oaknin, Isabelle Ray-Coquard, Maria I Harrell, Elaina Mann, Scott H Kaufmann, Anne Floquet, Alexandra Leary, Thomas C Harding, Sandra Goble, Lara Maloney, Jeff Isaacson, Andrew R Allen, Lindsey Rolfe, Roman Yelensky, Mitch Raponi, Iain A McNeish
BACKGROUND: Poly(ADP-ribose) polymerase (PARP) inhibitors have activity in ovarian carcinomas with homologous recombination deficiency. Along with BRCA1 and BRCA2 (BRCA) mutations genomic loss of heterozygosity (LOH) might also represent homologous recombination deficiency. In ARIEL2, we assessed the ability of tumour genomic LOH, quantified with a next-generation sequencing assay, to predict response to rucaparib, an oral PARP inhibitor. METHODS: ARIEL2 is an international, multicentre, two-part, phase 2, open-label study done at 49 hospitals and cancer centres in Australia, Canada, France, Spain, the UK, and the USA...
November 28, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27906454/immunotherapy-of-head-and-neck-cancer-emerging-clinical-trials-from-a-national-cancer-institute-head-and-neck-cancer-steering-committee-planning-meeting
#3
Julie E Bauman, Ezra Cohen, Robert L Ferris, David J Adelstein, David M Brizel, John A Ridge, Brian O'Sullivan, Barbara A Burtness, Lisa H Butterfield, William E Carson, Mary L Disis, Bernard A Fox, Thomas F Gajewski, Maura L Gillison, James W Hodge, Quynh-Thu Le, David Raben, Scott E Strome, Jean Lynn, Shakun Malik
Recent advances have permitted successful therapeutic targeting of the immune system in head and neck squamous cell carcinoma (HNSCC). These new immunotherapeutic targets and agents are being rapidly adopted by the oncologic community and hold considerable promise. The National Cancer Institute sponsored a Clinical Trials Planning Meeting to address the issue of how to further investigate the use of immunotherapy in patients with HNSCC. The goals of the meeting were to consider phase 2 or 3 trial designs primarily in 3 different patient populations: those with previously untreated, human papillomavirus-initiated oropharyngeal cancers; those with previously untreated, human papillomavirus-negative HNSCC; and those with recurrent/metastatic HNSCC...
December 1, 2016: Cancer
https://www.readbyqxmd.com/read/27902496/final-results-of-the-phase-iii-uro-bcg-4-multicenter-study-efficacy-and-tolerance-of-one-third-dose-bcg-maintenance-in-nonmuscle-invasive-bladder-cancer
#4
François X Nouhaud, Jérome Rigaud, Fabien Saint, Marc Colombel, Jacques Irani, Michel Soulie, Christian Pfister
To assess at 3 years bacillus Calmette-Guerin (BCG) maintenance treatment for NMIBC using one-third dose schedule and fewer instillations every 3 or 6 months. This was a phase III randomized study including patients with intermediate-risk or high-risk NMIBC, who received, after a full-dose induction schedule, three-weekly instillations of one-third dose BCG every 6 months (group I) and two-weekly instillations every 3 months (group II) during 3 years. We assessed oncological efficacy, BCG side effects, leukocyturia, and prostate-specific antigen...
November 29, 2016: Anti-cancer Drugs
https://www.readbyqxmd.com/read/27896440/a-phase-iii-open-label-randomized-multicenter-controlled-trial-of-oral-versus-intravenous-treosulfan-in-heavily-pretreated-recurrent-ovarian-cancer-a-study-of-the-north-eastern-german-society-of-gynecological-oncology-noggo
#5
Jalid Sehouli, Oliver Tomè, Desislava Dimitrova, Oumar Camara, Ingo Bernhard Runnebaum, Hans Werner Tessen, Beate Rautenberg, Radoslav Chekerov, Mustafa Zelal Muallem, Michael Patrick Lux, Tanja Trarbach, Gerald Gitsch
OBJECTIVE: In recurrent ovarian cancer (ROC), there is a high demand on effective therapies with a mild toxicity profile. Treosulfan is an alkylating agent approved as oral (p.o.) and intravenous (i.v.) formulation for the treatment of recurrent ovarian cancer. Data on safety and efficacy for either formulation are rare. For the first time we conducted a randomized phase III study comparing both formulations in women with ROC. METHODS: Patients having received at least two previous lines of chemotherapy were randomly assigned to one of two treatment arms: treosulfan i...
November 28, 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/27892773/real-world-data-on-nivolumab-treatment-of-non-small-cell-lung-cancer
#6
O T Brustugun, M Sprauten, Å Helland
BACKGROUND: Checkpoint inhibitors have proven effectiveness in clinical trials for non-small cell lung cancer (NSCLC) patients, but if this is congruent with routine patient care is discussed. We present real-world experience with the PD1-inhibitor nivolumab in NSCLC. PATIENTS AND METHODS: Patients with NSCLC were considered eligible for nivolumab treatment after one or more lines of chemotherapy, and when in reasonable performance status (PS) [Eastern Cooperative Oncology Group (ECOG) < 3]...
November 28, 2016: Acta Oncologica
https://www.readbyqxmd.com/read/27890073/switching-to-nilotinib-versus-imatinib-dose-escalation-in-patients-with-chronic-myeloid-leukaemia-in-chronic-phase-with-suboptimal-response-to-imatinib-lasor-a-randomised-open-label-trial
#7
Jorge E Cortes, Carmino Antonio De Souza, Manuel Ayala, Jose Luis Lopez, Eduardo Bullorsky, Sandip Shah, Xiaojun Huang, K Govind Babu, Kudrat Abdulkadyrov, José Salvador Rodrigues de Oliveira, Zhi-Xiang Shen, Tomasz Sacha, Israel Bendit, Zhizhou Liang, Tina Owugah, Tomasz Szczudlo, Sadhvi Khanna, Rafik Fellague-Chebra, Philipp D le Coutre
BACKGROUND: Optimal management of patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response remains undetermined. This study aimed to investigate the safety and efficacy of switching to nilotinib vs imatinib dose escalation for patients with suboptimal cytogenetic response on imatinib. METHODS: We did a phase 3, open-label, randomised trial in patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response to imatinib according to the 2009 European LeukemiaNet criteria, in Latin America, Europe, and Asia (59 hospitals and care centres in 12 countries)...
December 2016: Lancet Haematology
https://www.readbyqxmd.com/read/27884813/development-and-feasibility-testing-of-prompt-care-an-ehealth-system-for-collection-and-use-of-patient-reported-outcome-measures-for-personalized-treatment-and-care-a-study-protocol
#8
Afaf Girgis, Geoff P Delaney, Anthony Arnold, Alexis Andrew Miller, Janelle V Levesque, Nasreen Kaadan, Martin G Carolan, Nicole Cook, Kenneth Masters, Thomas T Tran, Tiffany Sandell, Ivana Durcinoska, Martha Gerges, Sandra Avery, Weng Ng, Stephen Della-Fiorentina, Haryana M Dhillon, Ashley Maher
BACKGROUND: Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. OBJECTIVE: This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research...
November 24, 2016: JMIR Research Protocols
https://www.readbyqxmd.com/read/27879974/nivolumab-dose-selection-challenges-opportunities-and-lessons-learned-for-cancer-immunotherapy
#9
Shruti Agrawal, Yan Feng, Amit Roy, Georgia Kollia, Brian Lestini
BACKGROUND: Immuno-oncology (I-O) therapies target the host immune system, providing the potential to choose a uniform dose and schedule across tumor types. However, dose selection for I-O agents usually occurs early in clinical development and is typically based on tumor response, which may not fully represent the potential for improved overall survival. Here, we describe an integrated approach which incorporates clinical safety and efficacy data with data obtained from analyses of dose-/exposure-response (D-R/E-R) relationships, used to select a monotherapy dose for nivolumab, a programmed death-1 inhibitor, in clinical studies of different tumor types...
2016: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/27876675/a-phase-1-1b-study-evaluating-trametinib-plus-docetaxel-or-pemetrexed-in-patients-with-advanced-non-small-cell-lung-cancer
#10
David R Gandara, Natasha Leighl, Jean-Pierre Delord, Fabrice Barlesi, Jaafar Bennouna, Gerald Zalcman, Jeffrey R Infante, Karen L Reckamp, Karen Kelly, Frances A Shepherd, Julien Mazieres, Filip Janku, Olivia S Gardner, Bijoyesh Mookerjee, Yuehui Wu, Donna S Cox, Dan Schramek, Vijay Peddareddigari, Yuan Liu, Anthony M D'Amelio, George Blumenschein
PURPOSE: This 2-part study evaluated trametinib, a MEK1/2 inhibitor, in combination with anticancer agents. Inhibition of MEK, a downstream effector of KRAS, demonstrated preclinical synergy with chemotherapy in KRAS-mutant non-small cell cancer (NSCLC) cell lines. Part 1 of this study identified recommended phase 2 doses of trametinib combinations. Part 2, reported herein, evaluated safety, tolerability, pharmacokinetics, and efficacy of trametinib combinations in patients with NSCLC with and without KRAS mutations...
November 19, 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27876603/canadian-phase-iii-randomized-trial-of-stereotactic-body-radiotherapy-versus-conventionally-hypofractionated-radiotherapy-for-stage-i-medically-inoperable-non-small-cell-lung-cancer-rationale-and-protocol-design-for-the-ontario-clinical-oncology-group-ocog
#11
Anand Swaminath, Marcin Wierzbicki, Sameer Parpia, James R Wright, Theodoros K Tsakiridis, Gordon S Okawara, Vijayananda Kundapur, Alexis Bujold, Naseer Ahmed, Khalid Hirmiz, Elizabeth Kurien, Edith Filion, Zsolt Gabos, Sergio Faria, Alexander V Louie, Timothy Owen, Elaine Wai, Kevin Ramchandar, Elisa K Chan, Jim Julian, Kathryn Cline, Timothy J Whelan
We describe a Canadian phase III randomized controlled trial of stereotactic body radiotherapy (SBRT) versus conventionally hypofractionated radiotherapy (CRT) for the treatment of stage I medically inoperable non-small-cell lung cancer (OCOG-LUSTRE Trial). Eligible patients are randomized in a 2:1 fashion to either SBRT (48 Gy in 4 fractions for peripherally located lesions; 60 Gy in 8 fractions for centrally located lesions) or CRT (60 Gy in 15 fractions). The primary outcome of the study is 3-year local control, which we hypothesize will improve from 75% with CRT to 87...
October 3, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27869081/long-term-update-of-nrg-oncology-rtog-0319-a-phase-1-and-2%C3%A2-trial-to-evaluate-3-dimensional-conformal-radiation-therapy-confined-to-the-region-of%C3%A2-the%C3%A2-lumpectomy-cavity-for-stage-i-and-ii-breast%C3%A2-carcinoma
#12
Rachel Rabinovitch, Jennifer Moughan, Frank Vicini, Helen Pass, John Wong, Susan Chafe, Ivy Petersen, Douglas W Arthur, Julia White
PURPOSE: NRG Oncology RTOG 0319 was the first cooperative group trial in the United States to evaluate 3-dimensional conformal radiation therapy (3D-CRT) accelerated partial breast irradiation (APBI). This report updates secondary endpoints of toxicity and efficacy. METHODS AND MATERIALS: Patients with stage I or II invasive breast cancer (tumor size ≤3 cm, ≤3 positive lymph nodes, negative margins) were eligible for 3D-CRT APBI: 38.5 Gy in 10 twice-daily fractions...
December 1, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/27866835/over-using-chemotherapy-in-the-adjuvant-setting
#13
Giuseppe Curigliano, Carmen Criscitiello, Angela Esposito, Giancarlo Pruneri
Avoidance of unnecessary or ineffective treatment should be one of the main goals in adjuvant breast oncology today. Unfortunately, both patients and doctors hunt for tiny statistical differences in survival curves. This search could not only lead to an oncological approach of unlimited addition that we will not be able to afford, but would also end inevitably in indeterminate overtreatment with substantial risks of unexpected toxic effects eating away whatever progress we might make. "Do not harm" remains the main principle in medicine...
November 17, 2016: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/27864705/the-clinical-and-financial-impact-of-a-pediatric-surgical-neuro-oncology-clinical-trial
#14
Eric M Thompson, Sridharan Gururangan, Gerald Grant, Duane Mitchell, John H Sampson
Pediatric surgical trials are rare and the impact of such trials on the institutions in which they are conducted is unknown. The purpose of this study was to analyze the clinical and financial impact of The Re-MATCH trial, a Phase I clinical trial requiring the biopsy or resection of recurrent medulloblastoma or PNET for enrollment. Inpatient financial and clinical volume information was collected during the 3 years of trial enrollment and the years preceding and following it. The primary endpoints were the difference in direct contribution margin (DCM), or net gain, of study and non-study patients and the difference in surgical volume during the study and non-study periods...
November 18, 2016: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/27859010/bevacizumab-combined-with-capecitabine-and-oxaliplatin-in-patients-with-advanced-adenocarcinoma-of-the-small-bowel-or-ampulla-of-vater-a-single-center-open-label-phase-2-study
#15
Pat Gulhati, Kanwal Raghav, Rachna T Shroff, Gauri R Varadhachary, Scott Kopetz, Milind Javle, Wei Qiao, Huamin Wang, Jeffrey Morris, Robert A Wolff, Michael J Overman
BACKGROUND: Capecitabine with oxaliplatin (CAPOX) has previously demonstrated clinical activity in patients with small bowel adenocarcinoma (SBA) and ampullary adenocarcinoma (AAC). Herein, the authors conducted a phase 2 trial to evaluate the benefit of adding bevacizumab to CAPOX. METHODS: In this phase 2, single-arm, single-center, open-label study, patients aged ≥18 years with untreated, advanced SBA or AAC were recruited. Patients received capecitabine at a dose of 750 mg/m(2) orally twice daily on days 1 to 14, oxaliplatin at a dose of 130 mg/m(2) intravenously on day 1, and bevacizumab at a dose of 7...
November 14, 2016: Cancer
https://www.readbyqxmd.com/read/27846913/induction-chemotherapy-for-locoregionally-advanced-nasopharyngeal-carcinoma
#16
Wen-Fei Li, Lei Chen, Ying Sun, Jun Ma
The value of adding induction chemotherapy (IC) to concurrent chemoradiotherapy (CCRT) for the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC) remains unclear. In our recent article entitled "Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial" published in the Lancet Oncology, we reported the results of a phase III, multicenter, randomized controlled trial comparing cisplatin, 5-fluorouracil, and docetaxel (TPF) IC plus CCRT versus CCRT alone in patients with T3-4N1/TxN2-3M0 NPC (ClinicalTrials...
November 15, 2016: Chinese Journal of Cancer
https://www.readbyqxmd.com/read/27843597/quality-of-life-during-first-line-folfox4%C3%A2-panitumumab-in-ras-wild-type-metastatic-colorectal-carcinoma-results-from-a-randomised-controlled-trial
#17
Salvatore Siena, Josep Tabernero, Gyorgy Bodoky, David Cunningham, Fernando Rivera, Paul Ruff, Jean Luc Canon, Reija Koukakis, Gaston Demonty, Guy Hechmati, Jean-Yves Douillard
INTRODUCTION: Metastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. METHODS: A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type RAS tumours (n=505)...
2016: ESMO Open
https://www.readbyqxmd.com/read/27843586/inter-institutional-heterogeneity-in-outcomes-of-chemotherapy-for-metastatic-gastric-cancer-correlative-study-in-the-jcog9912-phase-iii-trial
#18
Y Kurokawa, N Boku, T Yamaguchi, A Ohtsu, J Mizusawa, K Nakamura, H Fukuda
BACKGROUND: The standard chemotherapy regimen for gastric cancer has been established by several phase III trials. However, few studies have evaluated inter-institutional heterogeneity in randomised trials; such research may assure the generalisability of the results and also the reliability of the study group itself. PATIENTS AND METHODS: The Japan Clinical Oncology Group (JCOG)9912 phase III trial compared irinotecan plus cisplatin and S-1 alone with fluorouracil alone for metastatic gastric cancer, and finally demonstrated the non-inferiority of S-1 alone with respect to overall survival (OS)...
2016: ESMO Open
https://www.readbyqxmd.com/read/27843120/bortezomib-thalidomide-dexamethasone-and-panobinostat-for-patients-with-relapsed-multiple-myeloma-muk-six-a-multicentre-open-label-phase-1-2-trial
#19
Rakesh Popat, Sarah R Brown, Louise Flanagan, Andrew Hall, Walter Gregory, Bhuvan Kishore, Matthew Streetly, Heather Oakervee, Kwee Yong, Gordon Cook, Eric Low, Jamie Cavenagh
BACKGROUND: Panobinostat (a pan histone deacetylase inhibitor) is approved in combination with bortezomib and dexamethasone for patients with relapsed multiple myeloma who have received two or more previous lines of therapy. We aimed to improve the safety of this combination and investigate efficacy by incorporating low-dose thalidomide, using sub-cutaneous weekly bortezomib, and determining the maximum tolerated dose of panobinostat in this regimen. METHODS: We did a phase 1/2, multicentre, open-label trial (MUK six) at four hospitals in the UK, enrolling patients with relapsed, or relapsed and refractory, multiple myeloma aged at least 18 years, with an Eastern Cooperative Oncology Group performance status of 2 or less who had previously received 1-4 lines of therapy...
November 11, 2016: Lancet Haematology
https://www.readbyqxmd.com/read/27826132/increasing-complexity-in-rule-based-clinical-decision-support-the-symptom-assessment-and-management-intervention
#20
David F Lobach, Ellis B Johns, Barbara Halpenny, Toni-Ann Saunders, Jane Brzozowski, Guilherme Del Fiol, Donna L Berry, Ilana M Braun, Kathleen Finn, Joanne Wolfe, Janet L Abrahm, Mary E Cooley
BACKGROUND: Management of uncontrolled symptoms is an important component of quality cancer care. Clinical guidelines are available for optimal symptom management, but are not often integrated into the front lines of care. The use of clinical decision support (CDS) at the point-of-care is an innovative way to incorporate guideline-based symptom management into routine cancer care. OBJECTIVE: The objective of this study was to develop and evaluate a rule-based CDS system to enable management of multiple symptoms in lung cancer patients at the point-of-care...
November 8, 2016: JMIR Medical Informatics
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