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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/28093654/long-term-outcomes-of-laparoscopy-assisted-distal-gastrectomy-with-suprapancreatic-nodal-dissection-for-clinical-stage-i-gastric-cancer-a-multicenter-phase-ii-trial-jcog0703
#1
Naoki Hiki, Hitoshi Katai, Junki Mizusawa, Kenichi Nakamura, Mikihito Nakamori, Takaki Yoshikawa, Kazuyuki Kojima, Haruhiko Imamoto, Motoki Ninomiya, Seigo Kitano, Masanori Terashima
BACKGROUND: Laparoscopic gastrectomy has become a common surgical treatment for gastric cancer in eastern Asian countries. However, a large-scale prospective study to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) regarding long-term outcomes has never been reported. We have already reported the short-term outcomes of this study. Here we report long-term outcomes as the secondary endpoints of this study after a 5-year follow-up period. METHODS: This study comprised patients with clinical stage I gastric cancer who were able to undergo a distal gastrectomy...
January 16, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28093280/metronomics-in-the-neoadjuvant-and-adjuvant-treatment-of-breast-cancer
#2
Elisabetta Munzone, Marco Colleoni
The concept of metronomic chemotherapy (MC) has evolved from a descriptive preclinical phenomenon encompassing inhibition of angiogenesis to a clinically validated treatment concept involving multiple potential mechanisms of action. Clinicians are progressively more incline to consider MC as a component of mainstream medical oncology practice in advanced breast cancer. However, more recently MC has been tested even in the adjuvant/neoadjuvant setting, taking the opportunity to obtain tumor specimens and blood samples, in order to identify tumor-specific or patient-specific biomarkers for personalizing treatments...
January 13, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28089762/long-terms-results-of-a-trial-of-concurrent-chemotherapy-and-escalating-doses-of-radiation-for-unresectable-non-small-cell-lung-cancer-ncctg-n0028-alliance
#3
Steven E Schild, Shauna L Hillman, Angelina D Tan, Helen J Ross, William L McGinnis, Yolanda A Garces, David L Graham, Alex A Adjei, James R Jett
INTRODUCTION OR HYPOTHESIS: This phase I/II trial was originally designed to determine the maximally tolerated dose(MTD) of thoracic radiotherapy(TRT) as part of a combined modality approach. This report includes the long-term outcome of patients treated on this study. The phase II portion was never completed as RTOG-0617 opened before it was concluded. METHODS: The MTD was defined as 74Gy in 37 fractions in this study. Twenty-five patients with unresectable non-small cell lung cancer(NSCLC) were treated with 2Gy daily fractions and concurrent weekly carboplatin and paclitaxel...
January 12, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28078540/preplanned-safety-analysis-of-the-jfmc37-0801-trial-a-randomized-phase-iii-study-of-six-months-versus-twelve-months-of-capecitabine-as-adjuvant-chemotherapy-for-stage-iii-colon-cancer
#4
Takeshi Suto, Megumi Ishiguro, Chikuma Hamada, Katsuyuki Kunieda, Hiroyuki Masuko, Ken Kondo, Hideyuki Ishida, Genichi Nishimura, Kazuaki Sasaki, Takayuki Morita, Shoichi Hazama, Koutarou Maeda, Hideyuki Mishima, Hideyuki Ike, Sotaro Sadahiro, Kenichi Sugihara, Masazumi Okajima, Shigetoyo Saji, Junichi Sakamoto, Naohiro Tomita
BACKGROUND: Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis. METHODS: Patients aged 20-79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m(2)/day on days 1-14 of each 21-day cycle)...
January 11, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28074289/anamorelin-for-cancer-anorexia-cachexia-syndrome-a-systematic-review-and-meta-analysis
#5
REVIEW
Yu Bai, Yunxia Hu, Yanhua Zhao, Xizhong Yu, Junwei Xu, Zhiyun Hua, Zhiqiang Zhao
PURPOSE: The aim of this study was to evaluate the therapeutic effects of Anamorelin on patients with cancer anorexia-cachexia syndrome (CACS) based on a meta-analysis of published randomized trials. METHODS: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials databases. Data from each selected study were evaluated individually. All continuous outcomes were calculated by the mean difference or standardized mean difference with 95% confidence interval for each study...
January 10, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28073946/a-randomized-phase-iii-trial-of-comparing-two-dose-fractionations-stereotactic-body-radiotherapy-sbrt-for-medically-inoperable-stage-ia-non-small-cell-lung-cancer-or-small-lung-lesions-clinically-diagnosed-as-primary-lung-cancer-japan-clinical-oncology-group
#6
EDITORIAL
Tomoki Kimura, Yasushi Nagata, Junko Eba, Shuichi Ozawa, Satoshi Ishikura, Taro Shibata, Yoshinori Ito, Masahiro Hiraoka, Yasumasa Nishimura
A randomized Phase III trial commenced in Japan in February 2016. Currently, 42 Gy in four fractions of stereotactic body radiotherapy prescribed at the D95% of the planning target volume, which is considered equal to the commonly used 48 Gy in four fractions at the isocenter using an old dose calculation algorithm, is the standard treatment in Japan for medically inoperable Stage IA non-small cell lung cancer and small lung lesions clinically diagnosed as primary lung cancer. This study aims to examine the superiority of 55 Gy in four fractions over 42 Gy in four fractions...
January 9, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28072447/randomized-clinical-trial-comparing-standard-diet-with-perioperative-oral-immunonutrition-in-total-gastrectomy-for-gastric-cancer
#7
S Ida, N Hiki, H Cho, K Sakamaki, S Ito, K Fujitani, N Takiguchi, Y Kawashima, K Nishikawa, M Sasako, T Aoyama, M Honda, T Sato, S Nunobe, T Yoshikawa
BACKGROUND: Total gastrectomy for gastric cancer is associated with excessive weight loss and decreased calorie intake. Nutritional support using eicosapentaenoic acid modulates immune function and limits catabolism in patients with advanced cancer, but its impact in the perioperative period is unclear. METHODS: This was a randomized phase III clinical trial of addition of eicosapentaenoic acid-rich nutrition to a standard diet in patients having total gastrectomy for gastric cancer...
January 10, 2017: British Journal of Surgery
https://www.readbyqxmd.com/read/28069259/sex-differences-in-hazard-ratio-during-drug-treatment-of-non-small-cell-lung-cancer-in-major-clinical-trials-a-focused-data-review-and-meta-analysis
#8
Lishi Wang, Yanhong Cao, Mingji Ren, Amei Chen, Jinglin Cui, DiaJun Sun, Weikuan Gu
PURPOSE: Understanding how sex impacts the efficacy of anticancer agents is a crucial step toward personalized and precision medicine. This review and meta-analysis evaluated sex differences in hazard ratios (HRs) of progression-free survival and overall survival in representative Phase III clinical trials of non-small-cell lung cancer (NSCLC). METHODS: Data were extracted from 24 large-scale clinical trials that included 12,000 male and 7000 female patients. The data were examined for HR differences between subgroups by sex, smoking status, and age, and for potential sex-smoking status, sex-age, and sex-drug interactions, during cancer treatment...
January 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28069017/dose-escalation-of-stereotactic-body-radiotherapy-sbrt-for-locally-advanced-unresectable-pancreatic-cancer-patients-with-cyberknife-protocol-of-a-phase-i-study
#9
Shui-Wang Qing, Xiao-Ping Ju, Yang-Sen Cao, Huo-Jun Zhang
BACKGROUND: Dose escalation of SBRT for locally advanced pancreatic cancer patients had been reported in several studies in one or three fractions, and phase I protocol was developed to investigate the maximum tolerated dose with CyberKnife for locally advanced unresectable pancreatic cancer patients in five fractions. METHODS: The study is designed as a mono-center phase I study. The primary endpoint is to determine the maximum tolerated dose by frequency of III/IV GI (gastrointestinal) toxicity...
January 9, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28067166/stem-cell-genetic-therapy-for-fanconi-anemia-a-new-hope
#10
Helmut Hanenberg, Katharina Roellecke, Constanze Wiek
Fanconi anemia (FA) is a rare inherited DNA disorder clinically characterized by congenital malformations, progressive bone marrow failure, and cancer susceptibility. Due to a strong survival advantage of spontaneously corrected 'normal' hematopoietic stem cells (HSCs) in a few patients, FA is considered a model disorder for genetic correction of autologous stem cells, where genetically corrected stem cells and their progeny have a strong in vivo selective advantage, ultimately leading to normal hematopoiesis...
January 9, 2017: Current Gene Therapy
https://www.readbyqxmd.com/read/28064454/hgf-met-in-cancer-progression-and-biomarker-discovery
#11
REVIEW
Kunio Matsumoto, Masataka Umitsu, Dinuka M De Silva, Arpita Roy, Donald P Bottaro
Signaling driven by hepatocyte growth factor (HGF) and MET receptor facilitates conspicuous biological responses such as epithelial cell migration, 3-D morphogenesis, and survival. The dynamic migration and promotion of cell survival induced by MET activation are bases respectively for invasion-metastasis and resistance against targeted drugs in cancers. Recent studies indicated that MET in tumor-derived exosomes facilitates metastatic niche formation and metastasis in malignant melanoma. In lung cancer, gene amplification-induced MET activation and ligand-dependent MET activation in autocrine/paracrine manner are causes for resistance to EGF receptor tyrosine kinase inhibitors and ALK inhibitors...
January 8, 2017: Cancer Science
https://www.readbyqxmd.com/read/28045649/cost-effectiveness-of-pemetrexed-in-combination-with-cisplatin-as-first-line-treatment-for-patients-with-advanced-non-squamous-non-small-cell-lung-cancer-in-spain
#12
Jonathan González García, Fernando Gutiérrez Nicolás, Gloria Julia Nazco Casariego, Cristina Valcárcel Nazco, Jose Norberto Batista López, Juana Oramas Rodríguez
INTRODUCTION: Lung cancer is the third most frequent neoplastic tumour in Spain, with around 27 000 new cases diagnosed per year; 80-95% of these are non-small-cell cancer (NSCLC), and the majority of cases are diagnosed in advanced stages of the disease, and for this reason it is one of the oncologic conditions with higher mortality rates (21.4% mean survival at 5 years). The main treatment regimens used for first-line treatment of NSCLC are: cisplatin/pemetrexed (cis/pem), cisplatin/gemcitabine/ bevacizumab (cis/gem/bev), and carboplatin/paclitaxel/ bevacizumab (carb/pac/bev)...
January 1, 2017: Farmacia Hospitalaria
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
#13
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/28045115/skeletal-related-events-significantly-impact-health-related-quality-of-life-in-metastatic-castration-resistant-prostate-cancer-data-from-prevail-and-affirm-trials
#14
F Saad, C Ivanescu, D Phung, Y Loriot, S Abhyankar, T M Beer, B Tombal, S Holmstrom
BACKGROUND: We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. METHODS: Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments...
January 3, 2017: Prostate Cancer and Prostatic Diseases
https://www.readbyqxmd.com/read/28043166/pharmacokinetic-drug-evaluation-of-atezolizumab-for-the-treatment-of-locally-advanced-or-metastatic-urothelial-carcinoma
#15
Rutveej Patel, Megan Bock, Charles F Polotti, Sammy Elsamra
Muscle invasive bladder cancer (MIBC) is difficult to manage for patients who progress during or after initial chemotherapy regimens. Current regimens offer low response rates with high toxicities. The advent of immune checkpoint inhibitors may represent a new opportunity for effective management of these patients. Areas covered: Atezolizumab is an engineered humanized monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. It is administered intravenously and is given every 3 weeks as long as there is no evidence of tumor progression...
February 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28040660/quality-of-life-and-swallowing-with-standard-chemoradiotherapy-versus-accelerated-radiotherapy-and-panitumumab-in-locoregionally-advanced-carcinoma-of-the-head-and-neck-a-phase-iii-randomised-trial-from-the-canadian-cancer-trials-group-hn-6
#16
Jolie Ringash, John N Waldron, Lillian L Siu, Rosemary Martino, Eric Winquist, Jim R Wright, Abdenour Nabid, John H Hay, Alex Hammond, Khalil Sultanem, Sebastien Hotte, Carson Leong, Ali Abdel Halim El-Gayed, Farah Naz, Kevin Ramchandar, Timothy E Owen, Alexander Montenegro, Brian O'Sullivan, Bingshu E Chen, Wendy R Parulekar
AIM: To compare quality of life (QOL) between standard (SFX) chemoradiotherapy (arm A) and altered fractionation radiotherapy (AFX) with panitumumab (PMab; arm B). METHODS: Patients with T any N + M0 or T3-4N0M0 squamous cell head-neck carcinoma were randomised to SFX (70 Gy/35/7 wks) plus cisplatin (100 mg/m(2) IV × 3) versus AFX (70 Gy/35/6 wks) plus PMab (9 mg/kg IV × 3). QOL was collected at baseline, end of radiation therapy (RT) and 2, 4, 6, 12, 24 and 36 months post-RT using the Functional Assessment of Cancer Therapy Head and Neck (FACT-H&N), MD Anderson Dysphagia Index (MDADI) and SWAL-QOL...
December 29, 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/28030784/dutch-melanoma-treatment-registry-quality-assurance-in-the-care-of-patients-with-metastatic-melanoma-in-the-netherlands
#17
Anouk Jochems, Maartje G Schouwenburg, Brenda Leeneman, Margreet G Franken, Alfons J M van den Eertwegh, John B A G Haanen, Hans Gelderblom, Carin A Uyl-de Groot, Maureen J B Aarts, Franchette W P J van den Berkmortel, Willeke A M Blokx, Mathilde C Cardous-Ubbink, Gerard Groenewegen, Jan Willem B de Groot, Geke A P Hospers, Ellen Kapiteijn, Rutger H Koornstra, Wim H Kruit, Marieke W Louwman, Djura Piersma, Rozemarijn S van Rijn, Albert J Ten Tije, Gerard Vreugdenhil, Michel W J M Wouters, Jacobus J M van der Hoeven
BACKGROUND: In recent years, the treatment of metastatic melanoma has changed dramatically due to the development of immune checkpoint and mitogen-activated protein (MAP) kinase inhibitors. A population-based registry, the Dutch Melanoma Treatment Registry (DMTR), was set up in July 2013 to assure the safety and quality of melanoma care in the Netherlands. This article describes the design and objectives of the DMTR and presents some results of the first 2 years of registration. METHODS: The DMTR documents detailed information on all Dutch patients with unresectable stage IIIc or IV melanoma...
December 25, 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/28029313/safety-and-activity-of-mirvetuximab-soravtansine-imgn853-a-folate-receptor-alpha-targeting-antibody-drug-conjugate-in-platinum-resistant-ovarian-fallopian-tube-or-primary-peritoneal-cancer-a-phase-i-expansion-study
#18
Kathleen N Moore, Lainie P Martin, David M O'Malley, Ursula A Matulonis, Jason A Konner, Raymond P Perez, Todd M Bauer, Rodrigo Ruiz-Soto, Michael J Birrer
Purpose This phase I expansion cohort study evaluated the safety and clinical activity of mirvetuximab soravtansine (IMGN853), an antibody-drug conjugate consisting of a humanized anti-folate receptor alpha (FRα) monoclonal antibody linked to the tubulin-disrupting maytansinoid DM4, in a population of patients with FRα-positive and platinum-resistant ovarian cancer. Patients and Methods Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer received IMGN853 at 6...
December 28, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28029303/e1308-phase-ii-trial-of-induction-chemotherapy-followed-by-reduced-dose-radiation-and-weekly-cetuximab-in-patients-with-hpv-associated-resectable-squamous-cell-carcinoma-of-the-oropharynx-ecog-acrin-cancer-research-group
#19
Shanthi Marur, Shuli Li, Anthony J Cmelak, Maura L Gillison, Weiqiang J Zhao, Robert L Ferris, William H Westra, Jill Gilbert, Julie E Bauman, Lynne I Wagner, David R Trevarthen, Jahagirdar Balkrishna, Barbara A Murphy, Nishant Agrawal, A Dimitrios Colevas, Christine H Chung, Barbara Burtness
Purpose Human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) is treatment-responsive. Definitive chemoradiation results in high cure rates but causes long-term toxicity and may represent overtreatment of some patients. This phase II trial evaluated whether complete clinical response (cCR) to induction chemotherapy (IC) could select patients with HPV-associated OPSCC for reduced radiation dose as a means of sparing late sequelae. Methods Patients with HPV16 and/or p16-positive, stage III-IV OPSCC received three cycles of IC with cisplatin, paclitaxel, and cetuximab...
December 28, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28028730/exposure-response-and-tumor-growth-inhibition-analyses-of-the-monovalent-anti-c-met-antibody-onartuzumab-metmab-in-the-second-and-third-line-non-small-cell-lung-cancer
#20
Kelong Han, Pascal Chanu, Fredrik Jonsson, Helen Winter, René Bruno, Jin Jin, Mark Stroh
The phase III trial comparing onartuzumab + erlotinib vs. erlotinib in the second- and third-line non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). The objective was to assess whether doses higher than the phase III dose (15 mg/kg) might yield better efficacy without compromising the safety profile. Data were from 636 patients from the phase II and III NSCLC studies. Tumor growth inhibition (TGI) models were fit to longitudinal tumor size data to estimate individual TGI metrics including time to tumor re-growth (TTG)...
December 27, 2016: AAPS Journal
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