keyword
MENU ▼
Read by QxMD icon Read
search

Phase 3 oncology

keyword
https://www.readbyqxmd.com/read/29451696/randomized-phase-2-trial-of-pemetrexed-pemetrexed-bevacizumab-and-pemetrexed-carboplatin-bevacizumab-in-patients-with-stage-iiib-iv-non-small-cell-lung-cancer-and-an-eastern-cooperative-oncology-group-performance-status-of-2
#1
David R Spigel, John D Hainsworth, Mathew J Joseph, Dianna L Shipley, M Kelly Hagan, Dana S Thompson, Howard A Burris, F Anthony Greco
BACKGROUND: The best treatment for patients with advanced non-small cell lung cancer (NSCLC) and a poor performance status is not well defined. In this phase 2 trial, patients were randomized to receive treatment with either single-agent pemetrexed or 1 of 2 combination regimens. METHODS: Patients with newly diagnosed, histologically confirmed nonsquamous NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 were stratified by age and serum albumin level and were randomized (1:1:1) to 1 of 3 regimens: pemetrexed (arm 1), pemetrexed and bevacizumab (arm 2), or pemetrexed, carboplatin, and bevacizumab (arm 3)...
February 16, 2018: Cancer
https://www.readbyqxmd.com/read/29450468/activity-and-safety-of-cetuximab-plus-modified-folfoxiri-followed-by-maintenance-with-cetuximab-or-bevacizumab-for-ras-and-braf-wild-type-metastatic-colorectal-cancer-a-randomized-phase-2-clinical-trial
#2
Chiara Cremolini, Carlotta Antoniotti, Sara Lonardi, Giuseppe Aprile, Francesca Bergamo, Gianluca Masi, Roberta Grande, Giuseppe Tonini, Claudia Mescoli, Giovanni Gerardo Cardellino, Luigi Coltelli, Lisa Salvatore, Domenico Cristiano Corsi, Cristiana Lupi, Donatello Gemma, Monica Ronzoni, Emanuela Dell'Aquila, Federica Marmorino, Francesca Di Fabio, Maria Laura Mancini, Lorenzo Marcucci, Gabriella Fontanini, Vittorina Zagonel, Luca Boni, Alfredo Falcone
Importance: The combination of a triple-drug chemotherapy regimen with an anti-epidermal growth factor receptor (EGFR) agent as a first-line treatment of metastatic colorectal cancer (mCRC) showed promising activity along with safety concerns in single-arm phase 2 trials. The role of maintenance following chemotherapy and anti-EGFR and the optimal regimen to be adopted are not established. Objectives: To evaluate the activity and safety of cetuximab plus modified FOLFOXIRI (mFOLFOXIRI) and explore the role of maintenance with cetuximab or bevacizumab in RAS and BRAF wild-type mCRC...
February 15, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29450452/effect-of-neoadjuvant-chemotherapy-plus-regional-hyperthermia-on-long-term-outcomes-among-patients-with-localized-high-risk-soft-tissue-sarcoma-the-eortc-62961-esho-95-randomized-clinical-trial
#3
Rolf D Issels, Lars H Lindner, Jaap Verweij, Rüdiger Wessalowski, Peter Reichardt, Peter Wust, Pirus Ghadjar, Peter Hohenberger, Martin Angele, Christoph Salat, Zeljko Vujaskovic, Soeren Daugaard, Olav Mella, Ulrich Mansmann, Hans Roland Dürr, Thomas Knösel, Sultan Abdel-Rahman, Michael Schmidt, Wolfgang Hiddemann, Karl-Walter Jauch, Claus Belka, Alessandro Gronchi
Importance: Patients with soft tissue sarcoma are at risk for local recurrence and distant metastases despite optimal local treatment. Preoperative anthracycline plus ifosfamide chemotherapy improves outcome in common histological subtypes. Objective: To analyze whether the previously reported improvement in local progression-free survival by adding regional hyperthermia to neoadjuvant chemotherapy translates into improved survival. Design, Setting, and Participants: Open-label, phase 3 randomized clinical trial to evaluate the efficacy and toxic effects of neoadjuvant chemotherapy plus regional hyperthermia...
February 15, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29450203/real-life-experience-of-ceritinib-in-crizotinib-pretreated-alk-advanced-non-small-cell-lung-cancer-patients
#4
Jacques Cadranel, Alexis B Cortot, Hervé Lena, Bertrand Mennecier, Pascal Do, Eric Dansin, Julien Mazieres, Christos Chouaid, Maurice Perol, Fabrice Barlesi, Gilles Robinet, Sylvie Friard, Luc Thiberville, Clarisse Audigier-Valette, Alain Vergnenegre, Virginie Westeel, Khemaies Slimane, Alexandru Buturuga, Denis Moro-Sibilot, Benjamin Besse
Here we report our experience of ceritinib in crizotinib-pretreated patients with anaplastic lymphoma kinase ( ALK ) positive ( ALK + ) non-small cell lung cancer (NSCLC) in a French temporary authorisation for use (TAU) study. The French TAU study included crizotinib-pretreated patients with advanced ALK + or ROS proto-oncogene 1 positive ( ROS1 + ) tumours. Patients received oral ceritinib (750 mg·day -1 as a starting dose) and best tumour response (as evaluated by the investigator) and safety were reported every 3 months...
January 2018: ERJ Open Research
https://www.readbyqxmd.com/read/29446317/credentialing-of-radiotherapy-centres-in-australasia-for-trog-09-02-chisel-a-phase-iii-clinical-trial-on-stereotactic-ablative-body-radiotherapy-of-early-stage-lung-cancer
#5
Tomas Kron, Brent Chesson, Nicholas Hardcastle, Melissa Crain, Natalie Clements, Mark Burns, David Ball
OBJECTIVE: A randomised clinical trial comparing Stereotactic Ablative Body Radiotherapy (SABR) with conventional radiotherapy for early stage lung cancer has been conducted in Australia and New Zealand under the auspices of the TransTasman Radiation Oncology Group (NCT01014130). We report on the technical credentialing program as prerequisite for centres joining the trial. METHODS: Participating centres were asked to develop treatment plans for two test cases to assess their ability to create plans according to protocol...
February 15, 2018: British Journal of Radiology
https://www.readbyqxmd.com/read/29439857/axitinib-in-combination-with-pembrolizumab-in-patients-with-advanced-renal-cell-cancer-a-non-randomised-open-label-dose-finding-and-dose-expansion-phase-1b-trial
#6
Michael B Atkins, Elizabeth R Plimack, Igor Puzanov, Mayer N Fishman, David F McDermott, Daniel C Cho, Ulka Vaishampayan, Saby George, Thomas E Olencki, Jamal C Tarazi, Brad Rosbrook, Kathrine C Fernandez, Mariajose Lechuga, Toni K Choueiri
BACKGROUND: Previous studies combining PD-1 checkpoint inhibitors with tyrosine kinase inhibitors of the VEGF pathway have been characterised by excess toxicity, precluding further development. We hypothesised that axitinib, a more selective VEGF inhibitor than others previously tested, could be combined safely with pembrolizumab (anti-PD-1) and yield antitumour activity in patients with treatment-naive advanced renal cell carcinoma. METHODS: In this ongoing, open-label, phase 1b study, which was done at ten centres in the USA, we enrolled patients aged 18 years or older who had advanced renal cell carcinoma (predominantly clear cell subtype) with their primary tumour resected, and at least one measureable lesion, Eastern Cooperative Oncology Group performance status 0-1, controlled hypertension, and no previous systemic therapy for renal cell carcinoma...
February 9, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29438463/efficacy-and-safety-findings-from-dream-a-phase-iii-study-of-dhp107-oral-paclitaxel-versus-iv-paclitaxel-in-patients-with-advanced-gastric-cancer-after-failure-of-first-line-chemotherapy
#7
Y-K Kang, M-H Ryu, S H Park, J G Kim, J W Kim, S-H Cho, Y-L Park, S R Park, S Y Rha, M J Kang, J Y Cho, S Y Kang, S Y Roh, B-Y Ryoo, B-H Nam, Y-W Jo, K-E Yoon, S C Oh
Background: Paclitaxel is currently only available as an intravenous (IV) formulation. DHP107 is a novel oral formulation of lipid ingredients and paclitaxel. DHP107 demonstrated comparable efficacy, safety, and pharmacokinetics to IV paclitaxel as second-line therapy in patients with advanced gastric cancer (AGC). DREAM is a multicenter, open-label, prospective, randomized phase III study of patients with histologically/cytologically confirmed, unresectable/recurrent AGC after first-line therapy failure...
February 9, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29435872/a-phase-ii-trial-of-concurrent-chemoradiotherapy-with-weekly-paclitaxel-and-carboplatin-in-advanced-oesophageal-carcinoma
#8
Kuai-Le Zhao, Yi Xia, Yun-Hai Li, Yun Chen, Qi Liu, Jun-Hua Zhang, Jia-Ying Deng, Ta-Shan Ai, Han-Ting Zhu, Harun Badakhshi
BACKGROUND: This study was performed to assess the efficacy and feasibility of definitive chemoradiotherapy consisting of weekly doses of combined paclitaxel and carboplatin concurrent with radiation therapy, followed by 2 cycles of consolidation chemotherapy for advanced esophageal carcinoma. METHODS: Eligibility criteria included local, advanced, newly diagnosed and postoperative local regional lymph node metastasis; Eastern Cooperative Oncology Group (ECOG) score ≤ 2; and adequate organ function...
February 12, 2018: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29433850/lenvatinib-versus-sorafenib-in-first-line-treatment-of-patients-with-unresectable-hepatocellular-carcinoma-a-randomised-phase-3-non-inferiority-trial
#9
Masatoshi Kudo, Richard S Finn, Shukui Qin, Kwang-Hyub Han, Kenji Ikeda, Fabio Piscaglia, Ari Baron, Joong-Won Park, Guohong Han, Jacek Jassem, Jean Frederic Blanc, Arndt Vogel, Dmitry Komov, T R Jeffry Evans, Carlos Lopez, Corina Dutcus, Matthew Guo, Kenichi Saito, Silvija Kraljevic, Toshiyuki Tamai, Min Ren, Ann-Lii Cheng
BACKGROUND: In a phase 2 trial, lenvatinib, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor α, RET, and KIT, showed activity in hepatocellular carcinoma. We aimed to compare overall survival in patients treated with lenvatinib versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma. METHODS: This was an open-label, phase 3, multicentre, non-inferiority trial that recruited patients with unresectable hepatocellular carcinoma, who had not received treatment for advanced disease, at 154 sites in 20 countries throughout the Asia-Pacific, European, and North American regions...
February 9, 2018: Lancet
https://www.readbyqxmd.com/read/29426340/pd-l1-diagnostic-tests-a-systematic-literature-review-of-scoring-algorithms-and-test-validation-metrics
#10
REVIEW
Margarita Udall, Maria Rizzo, Juliet Kenny, Jim Doherty, SueAnn Dahm, Paul Robbins, Eric Faulkner
BACKGROUND: The programmed death receptor 1 (PD-1) protein is a cell-surface receptor on certain lymphocytes that, with its ligand programmed death ligand 1 (PD-L1), helps to down-regulate immune responses. Many cancer types express PD-L1 and evade immune recognition via the PD-1/PD-L1 interaction. Precision therapies targeting the PD-1/PD-L1 pathway have the potential to improve response and thereby offer a novel treatment avenue to some patients with cancer. However, this new therapeutic approach requires reliable methods for identifying patients whose cancers are particularly likely to respond...
February 9, 2018: Diagnostic Pathology
https://www.readbyqxmd.com/read/29423515/atezolizumab-mpdl3280a-monotherapy-for-patients-with-metastatic-urothelial-cancer-long-term-outcomes-from-a-phase-1-study
#11
Daniel P Petrylak, Thomas Powles, Joaquim Bellmunt, Fadi Braiteh, Yohann Loriot, Rafael Morales-Barrera, Howard A Burris, Joseph W Kim, Beiying Ding, Constanze Kaiser, Marcella Fassò, Carol O'Hear, Nicholas J Vogelzang
Importance: Atezolizumab (anti-programmed death ligand 1) has demonstrated safety and activity in advanced and metastatic urothelial carcinoma, but its long-term clinical profile remains unknown. Objective: To report long-term clinical outcomes with atezolizumab therapy for patients with metastatic urothelial carcinoma. Design, Setting, and Participants: Patients were enrolled in an expansion cohort of an ongoing, open-label, phase 1 study...
February 8, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29419331/-icorg-05-03-prospective-randomized-non-inferiority-phase-iii-trial-comparing-two-radiation-schedules-in-malignant-spinal-cord-compression-not-proceeding-with-surgical-decompression-the-quality-of-life-analysis
#12
K A Lee, M Dunne, C Small, P J Kelly, O McArdle, J O'Sullivan, D Hacking, M Pomeroy, J Armstrong, M Moriarty, A Clayton-Lea, I Parker, C D Collins, P Thirion
BACKGROUND: The optimal primary external beam radiation therapy (EBRT) radiation schedule for malignant epidural spinal cord compression (MSCC) remains to be determined. The ICORG 05-03 trial assessed if a 10 Gy single fraction radiation schedule was not inferior to one with 20 Gray (Gy) in five daily fractions, in terms of functional motor outcome, for the treatment of MSCC in patients not proceeding with surgical decompression. This article reports on two of the secondary endpoints, Quality of life (QoL), assessed according to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version 3...
February 8, 2018: Acta Oncologica
https://www.readbyqxmd.com/read/29413282/first-report-of-nrg-oncology-radiation-therapy-oncology-group-0622-a-phase-2-trial-of-samarium-153-followed-by-salvage-prostatic-fossa-irradiation-in-high-risk-clinically-nonmetastatic-prostate-cancer-after-radical-prostatectomy
#13
Richard K Valicenti, Stephanie L Pugh, Edouard J Trabulsi, Oliver Sartor, Eric C Ko, Michael R Girvigian, Seth A Rosenthal, Mark E Shaves, Jeannie H Hoffman-Censits, John Schallenkamp, Howard M Sandler
PURPOSE: To investigate the utility of 153Sm lexidronam (Quadramet) in the setting of men with prostate cancer status post radical prostatectomy who develop biochemical failure with no clinical evidence of osseous metastases. PATIENTS AND METHODS: Trial NRG Oncology RTOG 0622 is a single-arm phase 2 trial that enrolled men with pT2-T4, N0-1, M0 prostate cancer status post radical prostatectomy, who meet at least 1 of these biochemical failure criteria: (1) prostate-specific antigen (PSA) > 1...
March 1, 2018: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/29404979/nrg-oncology-rtog-9006-a-phase-iii-randomized-trial-of-hyperfractionated-radiotherapy-rt-and-bcnu-versus-standard-rt-and-bcnu-for-malignant-glioma-patients
#14
Arif N Ali, Peixin Zhang, W K Alfred Yung, Yuhchyau Chen, Benjamin Movsas, Raul C Urtasun, Christopher U Jones, Kwang N Choi, Jeff M Michalski, A Jennifer Fischbach, Arnold M Markoe, Christopher J Schultz, Marta Penas-Prado, Madhur K Garg, Alan C Hartford, Harold E Kim, Minhee Won, Walter J Curran
From 1990 to 1994, patients with newly diagnosed malignant gliomas were enrolled and randomized between hyperfractionated radiation (HFX) of 72.0 Gy in 60 fractions given twice daily and 60.0 Gy in 30 fractions given once daily. All patients received 80 mg/m2 of 1,3 bis(2 chloroethyl)-1 nitrosourea on days 1-3 q8 weeks for 1 year. Patients were stratified by age, KPS, and histology. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS) and toxicity...
February 5, 2018: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/29401241/results-of-a-multi-institutional-randomized-non-inferiority-phase-3-trial-of-accelerated-fractionation-versus-standard-fractionation-in-radiation-therapy-for-t1-2n0m0-glottic-cancer-japan-clinical-oncology-group-study-jcog0701
#15
T Kodaira, Y Kagami, T Shibata, N Shikama, Y Nishimura, S Ishikura, K Nakamura, Y Saito, Y Matsumoto, T Teshima, Y Ito, T Akimoto, K Nakata, T Toshiyasu, K Nakagawa, Y Nagata, T Nishimura, T Uno, M Kataoka, A Yorozu, M Hiraoka
Background: We assessed the non-inferiority of accelerated fractionation (AF) (2.4 Gy/fraction) compared with standard fractionation (SF) (2 Gy/fraction) regarding progression-free survival (PFS) in patients with T1-2N0M0 glottic cancer (GC). Patients and Methods: In this multi-institutional, randomized, phase 3 trial, patients were enrolled from 32 Japanese institutions. Key inclusion criteria were GC T1 - 2N0M0, age 20 - 80, Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1, and adequate organ function...
February 1, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29397460/ramucirumab-for-the-treatment-of-patients-with-gastric-or-gastroesophageal-junction-cancer-in-community-oncology-practices
#16
A Scott Paulson, Lisa M Hess, Astra M Liepa, Zhanglin Lin Cui, Kathleen M Aguilar, Jamyia Clark, William Schelman
BACKGROUND: Limited real-world research has investigated ramucirumab for the treatment of patients with gastric or gastroesophageal junction (GEJ) cancer. This study was designed to describe ramucirumab monotherapy or combination therapy use in a community oncology practice setting. METHODS: This was a retrospective observational cohort study to describe the treatment of adult patients with gastric or GEJ cancer who initiated ramucirumab treatment between 4/21/14 and 6/30/16 within the US Oncology Network...
February 3, 2018: Gastric Cancer
https://www.readbyqxmd.com/read/29397354/napabucasin-versus-placebo-in-refractory-advanced-colorectal-cancer-a-randomised-phase-3-trial
#17
Derek J Jonker, Louise Nott, Takayuki Yoshino, Sharlene Gill, Jeremy Shapiro, Atsushi Ohtsu, John Zalcberg, Michael M Vickers, Alice C Wei, Yuan Gao, Niall C Tebbutt, Ben Markman, Timothy Price, Taito Esaki, Sheryl Koski, Matthew Hitron, Wei Li, Youzhi Li, Nadine M Magoski, Chiang J Li, John Simes, Dongsheng Tu, Christopher J O'Callaghan
BACKGROUND: Napabucasin is a first-in-class cancer stemness inhibitor that targets STAT3, which is a poor prognostic factor in colorectal cancer. This study aimed to test napabucasin in advanced colorectal cancer. METHODS: This study was a double-blind randomised phase 3 trial done at 68 centres in Canada, Australia, New Zealand, and Japan. Patients with advanced colorectal cancer with a good Eastern Cooperative Oncology Group (ECOG) performance status (0-1) for whom all available standard therapies had failed were eligible for the study...
January 31, 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29396091/ibrutinib-lenalidomide-and-rituximab-in-relapsed-or-refractory-mantle-cell-lymphoma-philemon-a-multicentre-open-label-single-arm-phase-2-trial
#18
Mats Jerkeman, Christian Winther Eskelund, Martin Hutchings, Riikka Räty, Karin Fahl Wader, Anna Laurell, Helle Toldbod, Lone Bredo Pedersen, Carsten Utoft Niemann, Christina Dahl, Hanne Kuitunen, Christian H Geisler, Kirsten Grønbæk, Arne Kolstad
BACKGROUND: Regimens based on ibrutinib alone and lenalidomide and rituximab in combination show high activity in patients with relapsed or refractory mantle cell lymphoma. We hypothesised that the combination of all three drugs would improve efficacy compared with previously published data on either regimen alone. METHODS: In this multicentre, open-label, single-arm, phase 2 trial, we enrolled patients aged 18 years or older with relapsed or refractory mantle cell lymphoma who had previously been treated with at least one rituximab-containing regimen, an Eastern Cooperative Oncology Group performance status score of 0-3, and at least one site of measurable disease, and who met criteria for several laboratory-assessed parameters...
January 29, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/29395863/pembrolizumab-in-patients-with-thymic-carcinoma-a-single-arm-single-centre-phase-2-study
#19
Giuseppe Giaccone, Chul Kim, Jillian Thompson, Colleen McGuire, Bhaskar Kallakury, Joeffrey J Chahine, Maria Manning, Robin Mogg, Wendy M Blumenschein, Ming T Tan, Deepa S Subramaniam, Stephen V Liu, Ian M Kaplan, Justine N McCutcheon
BACKGROUND: Treatment options are limited for patients with thymic carcinoma. These aggressive tumours are not typically associated with paraneoplastic autoimmune disorders, and strong PD-L1 expression has been reported in thymic epithelial tumours. We aimed to assess the activity of pembrolizumab, a monoclonal antibody that targets PD-1, in patients with advanced thymic carcinoma. METHODS: We completed a single-arm phase 2 study of pembrolizumab in patients with recurrent thymic carcinoma who had progressed after at least one line of chemotherapy...
January 25, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29394327/estimation-of-clinical-trial-success-rates-and-related-parameters
#20
Chi Heem Wong, Kien Wei Siah, Andrew W Lo
Previous estimates of drug development success rates rely on relatively small samples from databases curated by the pharmaceutical industry and are subject to potential selection biases. Using a sample of 406 038 entries of clinical trial data for over 21 143 compounds from January 1, 2000 to October 31, 2015, we estimate aggregate clinical trial success rates and durations. We also compute disaggregated estimates across several trial features including disease type, clinical phase, industry or academic sponsor, biomarker presence, lead indication status, and time...
January 31, 2018: Biostatistics
keyword
keyword
75333
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"