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Phase 3 oncology

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https://www.readbyqxmd.com/read/29933095/sorafenib-in-combination-with-gemcitabine-plus-cisplatin-chemotherapy-in-metastatic-renal-collecting-duct-carcinoma-a-prospective-multicentre-single-arm-phase-2-study
#1
Xinan Sheng, Dengfeng Cao, Jianlin Yuan, Fangjian Zhou, Qiang Wei, Xiaodong Xie, Chuanliang Cui, Zhihong Chi, Lu Si, Siming Li, Lili Mao, Bin Lian, Bixia Tang, Xieqiao Yan, Xuan Wang, Yan Kong, Jie Dai, Xue Bai, Li Zhou, Jun Guo
BACKGROUND: Collecting duct carcinoma (CDC) is a rare type of renal cancer with a poor prognosis. As there are no standard guidelines for the management of metastatic CDC (mCDC), we evaluated the efficacy and safety of combined therapies of sorafenib, gemcitabine, plus cisplatin in patients with mCDC. MATERIALS AND METHODS: A prospective, multicentre, single-arm, open-label, phase 2 trial (ClinicalTrials.gov identifier NCT01762150) that enrolled 26 mCDC patients with no prior systemic chemotherapy...
June 19, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29931597/phase-ii-study-of-s-1-plus-oxaliplatin-130-mg-m-2-in-japanese-patients-with-advanced-gastric-cancer
#2
Yosuke Kito, Nozomu Machida, Sadayuki Kawai, Satoshi Hamauchi, Takahiro Tsushima, Akiko Todaka, Tomoya Yokota, Kentaro Yamazaki, Akira Fukutomi, Yusuke Onozawa, Kunihiro Tsuji, Hisashi Doyama, Yutaka Haraguchi, Koji Nakashima, Kenji Kunieda, Keisei Taku, Keita Mori, Hirofumi Yasui
PURPOSE: Although oxaliplatin 130 mg/m2 every 3 weeks was approved for advanced gastric cancer in Japan, data regarding S-1 plus oxaliplatin 130 mg/m2 (SOX130) are limited in Japanese patients with advanced gastric cancer. We investigated the feasibility and safety of SOX130 in Japanese patients with advanced gastric cancer. METHODS: Patients with unresectable or recurrent gastric adenocarcinoma, no previous chemotherapy, and Eastern Cooperative Oncology Group Performance Status of 0-1 were treated with SOX130...
June 21, 2018: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29929861/can-clinicopathological-parameters-predict-for-lymph-node-metastases-in-ypt0-2-rectal-carcinoma-results-of-the-cao-aro-aio-94-and-cao-aro-aio-04-phase-3-trials
#3
Jens Müller von den Grün, Arndt Hartmann, Rainer Fietkau, Michael Ghadimi, Torsten Liersch, Werner Hohenberger, Jürgen Weitz, Rolf Sauer, Christian Wittekind, Philipp Ströbel, Claus Rödel, Emmanouil Fokas
BACKGROUND: The advent of less radical surgical approaches has generated concern about leaving locoregional lymph node metastases (LNM) unresected that could lead to adverse outcome. We examined the prognostic role of clinicopathological factors for ypN-positivity in patients with ypT0-2 rectal carcinoma treated within the CAO/ARO/AIO-94 and CAO/ARO/AIO-04 randomized phase 3 trials. METHODS: The correlation of clinicopathological factors with ypN-status (ypN0 vs ypN1/2) was examined in n = 776 patients with ypT0-2 rectal carcinoma after preoperative CRT and total mesorectal excision surgery using Pearson's Chi-squared test for categorical variables and Kruskal-Wallis' test for continuous variables...
June 18, 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29926431/french-therapeutic-education-programme-aimed-at-improving-the-quality-of-life-of-laryngectomised-patients-and-their-close-relations-the-three-stages-observational-and-interventional-randomised-of-the-study-petal
#4
Natacha Heutte, Moumainn Abouzayd, Laetitia Plisson, Mélanie Trocmé, Mélanie Seillier, Véronique Christophe, Lydia Guittet, Guillaume Grandazzi, Emmanuel Babin
The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology. Total laryngectomy is a mutilating surgical procedure having a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important and alter the quality of life of patients and their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on some technical procedures during hospital admission...
June 20, 2018: Journal of Cancer Education: the Official Journal of the American Association for Cancer Education
https://www.readbyqxmd.com/read/29924704/effects-of-surgery-with-salvage-stereotactic-radiosurgery-versus-surgery-with-whole-brain-radiation-therapy-in-patients-with-one-to-four-brain-metastases-jcog0504-a-phase-iii-noninferiority-randomized-controlled-trial
#5
Takamasa Kayama, Shinya Sato, Kaori Sakurada, Junki Mizusawa, Ryo Nishikawa, Yoshitaka Narita, Minako Sumi, Yasuji Miyakita, Toshihiro Kumabe, Yukihiko Sonoda, Yoshiki Arakawa, Susumu Miyamoto, Takaaki Beppu, Kazuhiko Sugiyama, Hirohiko Nakamura, Motoo Nagane, Yoko Nakasu, Naoya Hashimoto, Mizuhiko Terasaki, Akira Matsumura, Eiichi Ishikawa, Toshihiko Wakabayashi, Yasuo Iwadate, Shiro Ohue, Hiroyuki Kobayashi, Manabu Kinoshita, Kenichiro Asano, Akitake Mukasa, Katsuyuki Tanaka, Akio Asai, Hideo Nakamura, Tatsuya Abe, Yoshihiro Muragaki, Koichi Iwasaki, Tomokazu Aoki, Takao Watanabe, Hikaru Sasaki, Shuichi Izumoto, Masahiro Mizoguchi, Takayuki Matsuo, Hideo Takeshima, Motohiro Hayashi, Hidefumi Jokura, Takashi Mizowaki, Eiji Shimizu, Hiroki Shirato, Masao Tago, Hiroshi Katayama, Haruhiko Fukuda, Soichiro Shibui
Purpose Whereas whole-brain radiotherapy (WBRT) has been the standard treatment of brain metastases (BMs), stereotactic radiosurgery (SRS) is increasingly preferred to avoid cognitive dysfunction; however, it has not been clearly determined whether treatment with SRS is as effective as that with WBRT or WBRT plus SRS. We thus assessed the noninferiority of salvage SRS to WBRT in patients with BMs. Patients and Methods Patients age 20 to 79 years old with performance status scores of 0 to 2-and 3 if caused only by neurologic deficits-and with four or fewer surgically resected BMs with only one lesion > 3 cm in diameter were eligible...
June 20, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29923085/characterization-of-adrenal-lesions-using-mdct-wash-out-parameters-diagnostic-accuracy-of-several-combinations-of-intermediate-and-delayed-phases
#6
Giovanni Foti, Giuseppe Malleo, Niccolò Faccioli, Andrea Guerriero, Lino Furlani, Giovanni Carbognin
PURPOSE: To evaluate the diagnostic accuracy of wash-out parameters calculated using multiple intermediate and delayed phases. MATERIALS AND METHODS: This prospective study had institutional review board approval and informed consent was obtained from all patients. Between January 2012 and October 2016, 108 consecutive oncologic patients (59 males, 49 females, mean age 52.6 years; 129 diagnosed lesions) underwent multiphasic CT protocol including unenhanced (UE), arterial (AE), portal (PE), 5-min (DE-5) and the 15-min (DE-15) delayed phases of adrenal glands...
June 19, 2018: La Radiologia Medica
https://www.readbyqxmd.com/read/29921512/a-phase-ii-evaluation-of-sunitinib-in-the-treatment-of-persistent-or-recurrent-clear-cell-ovarian-carcinoma-an-nrg-oncology-gynecologic-oncology-group-study-gog-254
#7
John K Chan, William Brady, Bradley J Monk, Jubilee Brown, Mark S Shahin, Peter G Rose, Jae-Hoon Kim, Angeles Alvarez Secord, Joan L Walker, David M Gershenson
OBJECTIVES: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. METHODS: All patients had one or two prior regimens with measurable disease. Tumors were at least 50% clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity...
June 16, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29914796/convection-enhanced-delivery-for-diffuse-intrinsic-pontine-glioma-a-single-centre-dose-escalation-phase-1-trial
#8
Mark M Souweidane, Kim Kramer, Neeta Pandit-Taskar, Zhiping Zhou, Sofia Haque, Pat Zanzonico, Jorge A Carrasquillo, Serge K Lyashchenko, Sunitha B Thakur, Maria Donzelli, Ryan S Turner, Jason S Lewis, Nai-Kong V Cheung, Steven M Larson, Ira J Dunkel
BACKGROUND: Diffuse intrinsic pontine glioma is one of the deadliest central nervous system tumours of childhood, with a median overall survival of less than 12 months. Convection-enhanced delivery has been proposed as a means to efficiently deliver therapeutic agents directly into the brainstem while minimising systemic exposure and associated toxic effects. We did this study to evaluate the safety of convection-enhanced delivery of a radioimmunotherapy agent targeting the glioma-associated B7-H3 antigen in children with diffuse intrinsic pontine glioma...
June 15, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29913254/patient-reported-outcomes-in-nrg-oncology-rtog-0938-evaluating-two-ultrahypofractionated-regimens-for-prostate-cancer
#9
Himanshu R Lukka, Stephanie L Pugh, Deborah W Bruner, Jean-Paul Bahary, Colleen A F Lawton, Jason A Efstathiou, Rajat J Kudchadker, Lee E Ponsky, Samantha A Seaward, Ian S Dayes, Darindra D Gopaul, Jeff M Michalski, Guila Delouya, Irving D Kaplan, Eric M Horwitz, Mack Roach, Wayne H Pinover, David C Beyer, John O Amanie, Howard M Sandler, Lisa A Kachnic
BACKGROUND: There is considerable interest in very short (ultrahypofractionated) radiotherapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience and resource allocation benefits. OBJECTIVE: To demonstrate that detectable changes in health related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline. DESIGN, SETTING, AND PARTICIPANTS: XXXX is a non-blinded randomized phase II study of NCCN low risk prostate cancer where each arm is compared to a historical control...
June 15, 2018: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/29912374/luteal-phase-anovulatory-follicles-result-in-the-production-of-competent-oocytes-intra-patient-paired-case-control-study-comparing-follicular-versus-luteal-phase-stimulations-in-the-same-ovarian-cycle
#10
Danilo Cimadomo, Alberto Vaiarelli, Silvia Colamaria, Elisabetta Trabucco, Carlo Alviggi, Roberta Venturella, Erminia Alviggi, Ramona Carmelo, Laura Rienzi, Filippo Maria Ubaldi
STUDY QUESTION: Are the mean numbers of blastocysts obtained from sibling cohorts of oocytes recruited after follicular phase and luteal phase stimulations (FPS and LPS) in the same ovarian cycle similar? SUMMARY ANSWER: The cohorts of oocytes obtained after LPS are larger than their paired-FPS-derived cohorts and show a comparable competence, thus resulting in a larger mean number of blastocysts. WHAT IS KNOWN ALREADY: Three theories of follicle recruitment have been postulated to date: (i) the 'continuous recruitment' theory, (ii) the 'single recruitment episode' theory and (iii) the 'wave' theory...
June 15, 2018: Human Reproduction
https://www.readbyqxmd.com/read/29908991/mage-a3-immunotherapeutic-as-adjuvant-therapy-for-patients-with-resected-mage-a3-positive-stage-iii-melanoma-derma-a-double-blind-randomised-placebo-controlled-phase-3-trial
#11
Brigitte Dreno, John F Thompson, Bernard Mark Smithers, Mario Santinami, Thomas Jouary, Ralf Gutzmer, Evgeny Levchenko, Piotr Rutkowski, Jean-Jacques Grob, Sergii Korovin, Kamil Drucis, Florent Grange, Laurent Machet, Peter Hersey, Ivana Krajsova, Alessandro Testori, Robert Conry, Bernard Guillot, Wim H J Kruit, Lev Demidov, John A Thompson, Igor Bondarenko, Jaroslaw Jaroszek, Susana Puig, Gabriela Cinat, Axel Hauschild, Jelle J Goeman, Hans C van Houwelingen, Fernando Ulloa-Montoya, Andrea Callegaro, Benjamin Dizier, Bart Spiessens, Muriel Debois, Vincent G Brichard, Jamila Louahed, Patrick Therasse, Channa Debruyne, John M Kirkwood
BACKGROUND: Despite newly approved treatments, metastatic melanoma remains a life-threatening condition. We aimed to evaluate the efficacy of the MAGE-A3 immunotherapeutic in patients with stage IIIB or IIIC melanoma in the adjuvant setting. METHODS: DERMA was a phase 3, double-blind, randomised, placebo-controlled trial done in 31 countries and 263 centres. Eligible patients were 18 years or older and had histologically proven, completely resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma with macroscopic lymph node involvement and an Eastern Cooperative Oncology Group performance score of 0 or 1...
June 13, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29907553/development-and-evaluation-of-an-ethical-guideline-for-decisions-to-limit-life-prolonging-treatment-in-advanced-cancer-protocol-for-a-monocentric-mixed-method-interventional-study
#12
Katsiaryna Laryionava, Katja Mehlis, Elena Bierwirth, Friederike Mumm, Wolfgang Hiddemann, Pia Heußner, Eva C Winkler
BACKGROUND: Many patients with advanced cancer receive chemotherapy close to death and are referred too late to palliative or hospice care, and therefore die under therapy or in intensive care units. Oncologists still have difficulties in involving patients appropriately in decisions about limiting tumor-specific or life-prolonging treatment. OBJECTIVE: The aim of this Ethics Policy for Advanced Care Planning and Limiting Treatment Study is to develop an ethical guideline for end-of-life decisions and to evaluate the impact of this guideline on clinical practice regarding the following target goals: reduction of decisional conflicts, improvement of documentation transparency and traceability, reduction of distress of the caregiver team, and better knowledge and consideration of patients' preferences...
June 15, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29907503/real-time-management-of-incident-learning-reports-in-a-radiation-oncology-department
#13
REVIEW
Jean L Wright, Arti Parekh, Byung-Han Rhieu, Valentina Opris, Annette Souranis, Amanda Choflet, Akila N Viswanathan, Theodore L DeWeese, Todd McNutt, Stephanie A Terezakis
PURPOSE: The optimal approach to managing incident learning system (ILS) reports remains unclear. Here, we describe our experience with prospective coding of events reported to the ILS with comparisons of risk scores on the basis of event type and process map location. METHODS AND MATERIALS: Reported events were coded by type, origin, and method of discovery. Events were given a risk priority number (RPN) and near-miss risk index (NMRI) score. We compared workflow versus near-miss events with respect to origin and detection in the process map and by risk scores...
May 8, 2018: Practical Radiation Oncology
https://www.readbyqxmd.com/read/29903505/randomised-phase-ii-feasibility-trial-of-image-guided-external-beam-radiotherapy-with-or-without-high-dose-rate-brachytherapy-boost-in-men-with-intermediate-risk-prostate-cancer-cctg-pr15-nct01982786
#14
E Vigneault, G Morton, W R Parulekar, T M Niazi, C W Springer, M Barkati, P Chung, W Koll, A Kamran, M Monreal, K Ding, A Loblaw
AIMS: We conducted a multicentre feasibility study to assess the ability to randomise patients between image-guided radiotherapy (IGRT) and IGRT + high dose rate (HDR) brachytherapy boost and to adhere to appropriate radiation quality assurance standards. MATERIALS AND METHODS: The primary end point was to determine the ability to randomise 60 patients over an 18 month period. Arm 1 (IGRT) patients received 78 Gy in 39 fractions or 60 Gy in 20 fractions (physician's preference), whereas arm 2 (IGRT + HDR) received 37...
June 11, 2018: Clinical Oncology: a Journal of the Royal College of Radiologists
https://www.readbyqxmd.com/read/29891263/treatment-design-and-rationale-for-a-randomized-trial-of-prophylactic-cranial-irradiation-with-or-without-hippocampal-avoidance-for-sclc-premer-trial-on-behalf-of-the-oncologic-group-for-the-study-of-lung-cancer-spanish-radiation-oncology-group-radiation-oncology
#15
Nuria Rodríguez de Dios, Felipe Couñago, José Luis López, Patricia Calvo, Mauricio Murcia, Mikel Rico, Carmen Vallejo, Javier Luna, Itziar Trueba, Cristina Cigarral, Nuria Farre, Rosa Maria Manero, Xavier Durán, Pilar Samper
BACKGROUND: Prophylactic cranial irradiation (PCI) is part of the usual treatment in most patients with small-cell lung cancer (SCLC) and response after treatment of the primary tumor. Clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy might play a role in radiation-induced neurocognitive decline. PATIENTS AND METHODS: This study is a multicenter phase III trial (NCT02397733) randomizing SCLC patients after informed consent, to receive standard PCI treatment or PCI with hippocampus avoidance (PCI-HA) by using intensity modulated radiation therapy or volumetric modulated arc therapy...
May 10, 2018: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29889468/long-term-follow-up-results-of-concomitant-chemoradiotherapy-followed-by-adjuvant-temozolomide-therapy-for-glioblastoma-multiforme-patients-the-importance-of-mri-information-in-survival-single-center-experience
#16
Gábor Lukács, Zoltán Tóth, Dávid Sipos, Melinda Csima, Janaki Hadjiev, Gábor Bajzik, Zsolt Cselik, Dávid Semjén, Imre Repa, Árpád Kovács
Background and purpose: Glioblastoma multiforme (GBM) is the most common malignant primary anomaly of central nervous system. The GBM infiltrates the nearly sturctures from the initial tumor and its metastatic attribution is well known. The aim of our single-centered retrospective study was to introduce the importance of postoperative medical imaging confirmation of total tumor resection for patient with GBM combined concomitant and adjuvant chemoradiotherapy on a 10 year long patient follow up...
March 30, 2018: Ideggyógyászati Szemle
https://www.readbyqxmd.com/read/29889137/randomized-prospective-open-label-phase-iii-trial-comparing-mebo-ointment-with-biafine-cream-for-the-management-of-acute-dermatitis-during-radiotherapy-for-breast-cancer
#17
Fady B Geara, Toufic Eid, Nicolas Zouain, Ranim Thebian, Therese Andraos, Chirine Chehab, Paul Ramia, Bassem Youssef, Youssef H Zeidan
PURPOSE: Acute radiation dermatitis is a common side-effect of radiotherapy in breast cancer and has a profound impact on patients' quality of life, due to pain and discomfort. The aim of this study is to compare the effect of β-sitosterol (Mebo) ointment to trolamine (Biafine) cream for the prevention and treatment of radiation dermatitis in breast cancer patients receiving adjuvant radiation therapy. MATERIALS AND METHODS: This is a prospective open-label randomized phase III study developed to assess the efficacy of 2 topical agents used for management of acute radiation dermatitis...
June 7, 2018: American Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29888206/a-phase-i-randomized-phase-ii-study-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-nintedanib-versus-sorafenib-in-asian-patients-with-advanced-hepatocellular-carcinoma
#18
Chia-Jui Yen, Tae-You Kim, Yin-Hsun Feng, Yee Chao, Deng-Yn Lin, Baek-Yeol Ryoo, Dennis Chin-Lun Huang, David Schnell, Julia Hocke, Arsène-Bienvenu Loembé, Ann-Lii Cheng
Background: Nintedanib is an oral, triple angiokinase inhibitor of vascular endothelial growth factor/platelet-derived growth factor/fibroblast growth factor receptors. This randomized, multicenter, open-label, phase I/II study evaluated the safety, pharmacokinetics, maximum tolerated dose (MTD) in terms of dose-limiting toxicities (DLTs), and efficacy of nintedanib versus sorafenib in Asian patients with unresectable advanced hepatocellular carcinoma (HCC). Patients and Methods: For the phase I portion, patients were stratified into two groups according to their alanine aminotransferase/aspartate aminotransferase (ALT/AST) and Child-Pugh score at baseline...
May 2018: Liver Cancer
https://www.readbyqxmd.com/read/29880292/efficacy-and-safety-of-abp-980-compared-with-reference-trastuzumab-in-women-with-her2-positive-early-breast-cancer-lilac-study-a-randomised-double-blind-phase-3-trial
#19
Gunter von Minckwitz, Marco Colleoni, Hans-Christian Kolberg, Serafin Morales, Patricia Santi, Zorica Tomasevic, Nan Zhang, Vladimir Hanes
BACKGROUND: ABP 980 (Amgen Inc, Thousand Oaks, CA, USA) is a biosimilar of trastuzumab, with analytical, functional, and pharmacokinetic similarities. We compared the clinical safety and efficacy of ABP 980 with that of trastuzumab in women with HER2-positive early breast cancer. METHODS: We did a randomised, multicentre, double-blind, active-controlled equivalence trial at 97 study centres in 20 countries, mainly in Europe and South America. Eligible women were aged 18 years or older, had histologically confirmed HER2-positive invasive early breast cancer, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and were planning to have surgical resection of the breast tumour with sentinel or axillary lymph node dissection and neoadjuvant chemotherapy...
June 4, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29880291/olaparib-combined-with-abiraterone-in-patients-with-metastatic-castration-resistant-prostate-cancer-a-randomised-double-blind-placebo-controlled-phase-2-trial
#20
Noel Clarke, Pawel Wiechno, Boris Alekseev, Nuria Sala, Robert Jones, Ivo Kocak, Vincenzo Emanuele Chiuri, Jacek Jassem, Aude Fléchon, Charles Redfern, Carsten Goessl, Joseph Burgents, Robert Kozarski, Darren Hodgson, Maria Learoyd, Fred Saad
BACKGROUND: Patients with metastatic castration-resistant prostate cancer and homologous recombination repair (HRR) mutations have a better response to treatment with the poly(ADP-ribose) polymerase inhibitor olaparib than patients without HRR mutations. Preclinical data suggest synergy between olaparib and androgen pathway inhibitors. We aimed to assess the efficacy of olaparib plus the androgen pathway inhibitor abiraterone in patients with metastatic castration-resistant prostate cancer regardless of HRR mutation status...
June 4, 2018: Lancet Oncology
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