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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/28226332/responsible-safe-and-effective-prescription-of-opioids-for-chronic-non-cancer-pain-american-society-of-interventional-pain-physicians-asipp-guidelines
#1
Laxmaiah Manchikanti, Adam M Kaye, Nebojsa Nick Knezevic, Heath McAnally, Konstantin Slavin, Andrea M Trescot, Susan Blank, Vidyasagar Pampati, Salahadin Abdi, Jay S Grider, Alan D Kaye, Kavita N Manchikanti, Harold Cordner, Christopher G Gharibo, Michael E Harned, Sheri L Albers, Sairam Atluri, Steve M Aydin, Sanjay Bakshi, Robert L Barkin, Ramsin M Benyamin, Mark V Boswell, Ricardo M Buenaventura, Aaron K Calodney, David L Cedeno, Sukdeb Datta, Timothy R Deer, Bert Fellows, Vincent Galan, Vahid Grami, Hans Hansen, Standiford Helm Ii, Rafael Justiz, Dhanalakshmi Koyyalagunta, Yogesh Malla, Annu Navani, Kent H Nouri, Ramarao Pasupuleti, Nalini Sehgal, Sanford M Silverman, Thomas T Simopoulos, Vijay Singh, Daneshvari R Solanki, Peter S Staats, Ricardo Vallejo, Bradley W Wargo, Arthur Watanabe, Joshua A Hirsch
BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl...
February 2017: Pain Physician
https://www.readbyqxmd.com/read/28219023/phase-ii-trials-in-osteosarcoma-recurrences-a-systematic-review-of-past-experience
#2
REVIEW
Natacha Omer, Marie-Cécile Le Deley, Sophie Piperno-Neumann, Perrine Marec-Berard, Antoine Italiano, Nadège Corradini, Carine Bellera, Laurence Brugières, Nathalie Gaspar
BACKGROUND: The most appropriate design of Phase-II trials evaluating new therapies in osteosarcoma remains poorly defined. OBJECTIVE: To study consistency in phase-II clinical trials evaluating new therapies for osteosarcoma recurrences with respect to eligibility criteria, response assessment, end-points, statistical design and reported results. METHODS: Systematic review of clinical trials registered on clinicaltrials.gov, clinicaltrialsregister...
February 17, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28217463/prostate-cancer-and-hypofractionation-reflections-on-recent-randomised-phase-iii-clinical-trial-results
#3
COMMENT
David Dearnaley, Emma Hall
No abstract text is available yet for this article.
February 2017: Translational Andrology and Urology
https://www.readbyqxmd.com/read/28217012/-68-ga-prostate-specific-membrane-antigen-positron-emission-tomography-computed-tomography-for-prostate-cancer-imaging-a-narrative-literature-review
#4
REVIEW
Jose M Oliveira, Catarina Gomes, Diogo B Faria, Tiago S Vieira, Fernando A Silva, Joana Vale, Francisco L Pimentel
The (68)Ga-prostate-specific membrane antigen ( (68)Ga-PSMA) has been recently developed to be used, as a ligand, in positron emission tomography/computed tomography (PET/CT) prostate cancer imaging, to detect prostate disease. The main objective of this review was to collect data and findings from other studies and articles to assess, theoretically, if (68)GA-PSMA PET/CT is a more appropriate prostate cancer diagnostic technique in comparison with others available such as CT, (18)F-fluoro-2-deoxyglucose PET/CT, or (18)F-fluoromethylcholine ( (18)F-choline) PET/CT...
January 2017: World Journal of Nuclear Medicine
https://www.readbyqxmd.com/read/28212543/metabotropic-glutamate-receptors-as-a-new-therapeutic-target-for-malignant-gliomas
#5
REVIEW
Mery Stefani Leivas Pereira, Fábio Klamt, Chairini Cássia Thomé, Paulo Valdeci Worm, Diogo Losch de Oliveira
Metabotropic glutamate receptors (mGluR) are predominantly involved in maintenance of cellular homeostasis of central nervous system. However, evidences have suggested other roles of mGluR in human tumors. Aberrant mGluR signaling has been shown to participate in transformation and maintenance of various cancer types, including malignant brain tumors. This review intends to summarize recent findings regarding the involvement of mGluR-mediated intracellular signaling pathways in progression, aggressiveness, and recurrence of malignant gliomas, mainly glioblastomas (GBM), highlighting the potential therapeutic applications of mGluR ligands...
February 12, 2017: Oncotarget
https://www.readbyqxmd.com/read/28209746/a-phase-ii-randomized-trial-go27827-of-first-line-folfox-plus-bevacizumab-with-or-without-the-met-inhibitor-onartuzumab-in-patients-with-metastatic-colorectal-cancer
#6
Johanna C Bendell, Howard Hochster, Lowell L Hart, Irfan Firdaus, Joseph R Mace, Joshua J McFarlane, Mark Kozloff, Daniel Catenacci, Jessie J Hsu, Stephen P Hack, David S Shames, See-Chun Phan, Hartmut Koeppen, Allen L Cohn
BACKGROUND: Dysregulated hepatocyte growth factor/mesenchymal-epithelial transition (MET) signaling is associated with poor prognosis and resistance to vascular endothelial growth factor inhibition in metastatic colorectal cancer (mCRC). We report outcomes from a double-blind, multicenter phase II trial of the MET inhibitor onartuzumab in combination with mFOLFOX-6 and bevacizumab for mCRC (GO27827; NCT01418222). MATERIALS AND METHODS: Patients were randomized 1:1 to receive onartuzumab (10 mg/kg intravenously [IV]) or placebo plus mFOLFOX-6 and bevacizumab (5 mg/kg IV)...
February 16, 2017: Oncologist
https://www.readbyqxmd.com/read/28205060/validation-of-the-jcog-prognostic-index-in-advanced-gastric-cancer-using-individual-patient-data-from-the-spirits-and-g-sox-trials
#7
Daisuke Takahari, Junki Mizusawa, Wasaburo Koizumi, Ichinosuke Hyodo, Narikazu Boku
BACKGROUND: In a phase III study for advanced gastric cancer (AGC), the Japan Clinical Oncology Group (JCOG) 9912 trial, we previously identified the following four prognostic factors-performance status ≥1, number of metastatic sites ≥2, no prior gastrectomy, and abnormal serum alkaline phosphatase levels-and proposed a prognostic index (good risk with 0 or 1 factor, moderate risk with 2 or 3 factors, and poor risk with all 4 factors). To assess the generalizability of this index, we attempted an external validation study using an independent data set...
February 16, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28202353/the-potential-clinical-promise-of-multimodality-metronomic-chemotherapy-revealed-by-preclinical-studies-of-metastatic-disease
#8
Robert S Kerbel, Yuval Shaked
We present a rationale for further clinical development and assessment of metronomic chemotherapy on the basis of unexpected results obtained in translational mouse models of cancer involving treatment of advanced metastatic disease. Historically, mouse cancer therapy models have been dominated by treating established primary tumors or early stage low volume microscopic disease. Treatment of primary tumors is also almost always the case when using genetically engineered mouse models (GEMMS) of cancer or patient-derived xenografts (PDXs)...
February 12, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28193231/association-of-osteopontin-with-specific-prognostic-factors-and-survival-in-adjuvant-breast-cancer-trials-of-the-hellenic-cooperative-oncology-group
#9
Amanda Psyrri, Konstantine T Kalogeras, Ralph M Wirtz, George Kouvatseas, Georgia Karayannopoulou, Anna Goussia, Flora Zagouri, Elke Veltrup, Eleni Timotheadou, Helen Gogas, Angelos Koutras, Georgios Lazaridis, Christos Christodoulou, George Pentheroudakis, Panagiota Economopoulou, Apostolos Laskarakis, Petroula Arapantoni-Dadioti, Anna Batistatou, Maria Sotiropoulou, Gerasimos Aravantinos, Pavlos Papakostas, Paris Kosmidis, Dimitrios Pectasides, George Fountzilas
BACKGROUND: The shift towards an earlier diagnosis of breast cancer (BC) highlights the need for biomarkers that would identify patients at risk for relapse and metastatic spread and indicate the potential value of additional treatment strategies. Osteopontin (OPN) is a matricellular protein that has been suggested to be a potential biomarker in BC. In the present study, we used archived BC patient samples to assess the clinical utility of OPN. METHODS: Formalin-fixed paraffin-embedded tumor tissue samples from 975 patients were collected from two large phase III randomized adjuvant chemotherapy trials (HE10/97 and HE10/00) that included patients with high risk BC...
February 13, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28192641/effects-of-induction-docetaxel-platinum-and-fluorouracil-chemotherapy-in-patients-with-stage-iii-or-iva-b-nasopharyngeal-cancer-treated-with-concurrent-chemoradiation-therapy-final-results-of-2-parallel-phase-2-clinical-trials
#10
Lin Kong, Youwang Zhang, Chaosu Hu, Ye Guo, Jiade J Lu
BACKGROUND: The effects of docetaxel, platinum, and fluorouracil (TPF) induction chemotherapy plus concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal cancer (NPC) are unclear. This study examined the long-term outcomes of the addition of this regimen to CCRT for stage III and IVA/B NPC. METHODS: Two parallel, single-arm phase 2 trials were performed synchronously to evaluate the efficacy and toxicity of TPF-based induction chemotherapy in patients with stage III or IVA/B NPC...
February 13, 2017: Cancer
https://www.readbyqxmd.com/read/28190762/optimal-fractionation-of-preoperative-radiotherapy-and-timing-to-surgery-for-rectal-cancer-stockholm-iii-a-multicentre-randomised-non-blinded-phase-3-non-inferiority-trial
#11
Johan Erlandsson, Torbjörn Holm, David Pettersson, Åke Berglund, Björn Cedermark, Calin Radu, Hemming Johansson, Mikael Machado, Fredrik Hjern, Olof Hallböök, Ingvar Syk, Bengt Glimelius, Anna Martling
BACKGROUND: Radiotherapy reduces the risk of local recurrence in rectal cancer. However, the optimal radiotherapy fractionation and interval between radiotherapy and surgery is still under debate. We aimed to study recurrence in patients randomised between three different radiotherapy regimens with respect to fractionation and time to surgery. METHODS: In this multicentre, randomised, non-blinded, phase 3, non-inferiority trial (Stockholm III), all patients with a biopsy-proven adenocarcinoma of the rectum, without signs of non-resectability or distant metastases, without severe cardiovascular comorbidity, and planned for an abdominal resection from 18 Swedish hospitals were eligible...
February 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28187041/laparoscopy-assisted-versus-open-d2-distal-gastrectomy-for-advanced-gastric-cancer-results-from-a-randomized-phase-ii-multicenter-clinical-trial-coact-1001
#12
Young Kyu Park, Hong Man Yoon, Young-Woo Kim, Ji Yeon Park, Keun Won Ryu, Young-Joon Lee, Oh Jeong, Ki Young Yoon, Jun Ho Lee, Sang Eok Lee, Wansik Yu, Sang-Ho Jeong, Taebong Kim, Sohee Kim, Byoung-Ho Nam
OBJECTIVE: This randomized, phase II, multicenter clinical trial was conducted to evaluate the feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for the treatment of advanced gastric cancer (AGC). SUMMARY OF BACKGROUND DATA: D2 lymph node dissection has been accepted as standard treatment for AGC. Although LADG is widely performed in early gastric cancer (EGC), the feasibility of LADG in AGC has not been proven yet...
February 9, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28183255/melanoma-adjuvant-treatment-current-insight-and-clinical-features
#13
Carmine D Aniello, Francesco Perri, Giuseppina Della Vittoria Scarpati, Chiara Della Pepa, Salvatore Pisconti, Vincenzo Montesarchio, Nicolas Wernert, Mayra Rachele Zarone, Michele Caraglia, Gaetano Facchini, Massimiliano Berretta, Carla Cavaliere
Melanoma represents 2-3% of all cancers, 95% of them arise from skin, while only 5% are non-cutaneous melanoma. Despite an optimal surgery management, the risk of a local and systemic relapse remains high, particularly in high-risk patients (node-positive or node-negative T3b, T4 a/b). We conducted a systematic review of the main published and ongoing phase I/II/III trials between 2000 and June 2015 on the adjuvant treatment of cutaneous melanoma. The IFN remains the only option currently available for this aim...
February 8, 2017: Current Cancer Drug Targets
https://www.readbyqxmd.com/read/28183254/metastatic-colorectal-cancer-role-of-target-therapies-and-future-perspectives
#14
Anna Nappi, Massimiliano Berretta, Carmela Romano, Salvatore Tafuto, Antonino Cassata, Rossana Casaretti, Lucrezia Silvestro, Chiara De Divitiis, Lara Alessandrini, Francesco Fiorica, Alessandro Ottaiano, Guglielmo Nasti
Today, we are experiencing a real cultural revolution in the therapeutic approach to cancer of the colon - rectum, that, by orphan disease, it is now becoming an important paradigm of scientific innovations and concepts. Survival of patients with metastatic colorectal cancer (m-CRC) has been significantly improved with the introduction of the monoclonal antibodies that have as target the vascular endothelial growth factor (VEGF) and the epidermal growth factor receptor (EGFR). Novel agents such as aflibercept and regorafenib have recently been approved...
February 8, 2017: Current Cancer Drug Targets
https://www.readbyqxmd.com/read/28177921/axillary-staging-in-breast-cancer-patients-treated-with-neoadjuvant-chemotherapy-in-two-dutch-phase-iii-studies
#15
Birgit E P J Vriens, Kristien B M I Keymeulen, Judith R Kroep, Ayoub Charehbili, Petronella G Peer, Maaike de Boer, Maureen J B Aarts, Esther M Heuts, Vivianne C G Tjan-Heijnen, The Dutch Breast Cancer Research Group Boog
BACKGROUND: Primary aim of our study was to assess the impact of timing of sentinel node procedure, pre- versus post-neoadjuvant chemotherapy, on final pathologic node-negative rate (pN0) in patients with clinically node-negative (cN0) breast cancer. Secondary endpoint was the usability of the sentinel node procedure in patients with clinically node-positive disease that converted to cN0 after neoadjuvant chemotherapy. PATIENTS AND METHODS: Patients were enrolled in two sequentially conducted Dutch phase III trials, studying the impact of two neoadjuvant chemotherapy schedules and use of zoledronic acid on complete pathologic response rate...
February 4, 2017: Oncotarget
https://www.readbyqxmd.com/read/28169231/palbociclib-a-new-hope-in-the-treatment-of-breast-cancer
#16
REVIEW
R Priyadharsini Palanisamy
Breast cancer being one of the common cancers has high morbidity and mortality. Despite the conventional treatment, the burden of the disease increases year after year. There is a need for newer drugs that target the different mechanisms in the pathogenesis. The interaction of cyclins with cyclin dependent kinases (CDKs) plays a major role in the abnormal cell cycle in cancer and it is considered to be an important target. Palbociclib is a CDK inhibitor currently approved for the treatment of breast cancer...
October 2016: Journal of Cancer Research and Therapeutics
https://www.readbyqxmd.com/read/28162945/postoperative-adjuvant-systemic-therapy-in-completely-resected-non-small-cell-lung-cancer-a-systematic-review
#17
REVIEW
Penelope Bradbury, Duvaraga Sivajohanathan, Adrien Chan, Swati Kulkarni, Yee Ung, Peter M Ellis
The purpose of the present review was to determine whether the use of postoperative adjuvant systemic therapy in patients with completely resected non-small-cell lung cancer (NSCLC) improves survival. Cancer Care Ontario's Program in Evidence-Based Care reviewed the evidence to update previously published recommendations for patients with completely resected NSCLC. Relevant studies were identified from a systematic MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews search of studies published from 2010 to 2016...
July 12, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28150022/efficacy-and-safety-of-neoadjuvant-chemotherapy-with-oxaliplatin-5-fluorouracil-and-levofolinate-for-t3-or-t4-stage-ii-iii-rectal-cancer-the-fact-trial
#18
Junichi Koike, Kimihiko Funahashi, Kazuhiko Yoshimatsu, Hajime Yokomizo, Hayato Kan, Takeshi Yamada, Hideyuki Ishida, Keiichiro Ishibashi, Yoshihisa Saida, Toshiyuki Enomoto, Kenji Katsumata, Masayuki Hisada, Hirotoshi Hasegawa, Keiji Koda, Takumi Ochiai, Kazuhiro Sakamoto, Hiroyuki Shiokawa, Shimpei Ogawa, Michio Itabashi, Shingo Kameoka
PURPOSE: A multicenter phase II clinical study was performed in patients with T3 or T4 stage II/III rectal cancer to evaluate the efficacy and safety of neoadjuvant chemotherapy with 5-fluorouracil, levofolinate, and oxaliplatin (mFOLFOX6). METHODS: Patients received four 2-week cycles of mFOLFOX6 therapy (oxaliplatin at 85 mg/m(2) + leucovorin at 200 mg/m(2) + fluorouracil as a 400 mg/m(2) bolus followed by infusion of 2400 mg/m(2) over 46 h, all on Day 1)...
February 1, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28149332/the-immunomodulatory-anticancer-agent-rrx-001-induces-an-interferon-response-through-epigenetic-induction-of-viral-mimicry
#19
Hongjuan Zhao, Shoucheng Ning, Rosalie Nolley, Jan Scicinski, Bryan Oronsky, Susan J Knox, Donna M Peehl
BACKGROUND: RRx-001, a dinitroazetidine derivative, is a novel anticancer agent currently in phase II clinical trials. It mediates immunomodulatory effects either directly through polarization of tumor associated macrophages or indirectly through vascular normalization and increased T-lymphocyte infiltration. With multiple additional mechanisms of action including upregulation of oxidative stress, depletion of GSH and NADPH, anti-angiogenesis and epigenetic modulation, RRx-001 is being studied as a radio- and chemo-sensitizer to resensitize tumors to prior therapy and to prime tumors to respond to radiation, chemotherapy and immunotherapy in combination therapy studies...
2017: Clinical Epigenetics
https://www.readbyqxmd.com/read/28148892/targeted-therapies-for-gastric-cancer-failures-and-hopes-from-clinical-trials
#20
Maria Apicella, Simona Corso, Silvia Giordano
Gastric cancer is the third leading cause of cancer mortality worldwide. As surgery is the only curative treatment strategy and conventional chemotherapy has shown limited efficacy -with a median overall survival of 10 months- new treatments are urgently needed. Trastuzumab and Ramucirumab (targeting HER2 and VEGFR2, respectively) are the only targeted therapies approved so far. Indeed, most Phase III clinical trials evaluating molecular drugs in gastric cancer failed. This review will retrace the relevant clinical trials with molecular therapies performed in gastric cancer patients, discussing the possible reasons for their failure and indicating new perspective for a real improvement of the treatment of this disease...
January 26, 2017: Oncotarget
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