rtog 95 17 phase ii apbi trial

... target RTKs through a dominant receptor pathway and have been investigated in phase II- III studies in patients with AGC [17] However, in many tumors, several RTKs are co-expressed [8] In addition, ... inhibition In two recent phase II studies in patients with chemorefractory AGC, SUN showed promising activity and manageable toxicity [28, 29] Therefore, this phase II clinical trial was conducted ... in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial J Clin Oncol 2012;30 (17) :2119–27 Moehler et al BMC Cancer (2016) 16:699 13 de Haas S, Delmar P, Bansal

Ngày tải lên: 20/09/2020, 17:54

... BMC Cancer (2015) 15:602 DOI 10.1186/s12885-015-1598-x STUDY PROTOCOL Open Access PATHOS: a phase II/ III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral ... disease-specific survival outcomes Methods/Design: The study is a multicentre phase II/ III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal ... will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint (Continued on next page) * Correspondence: HurtCN@cardiff.ac.uk Wales Cancer Trials Unit, 6th Floor,

Ngày tải lên: 28/09/2020, 01:30

... Radice6 and Bernardo Bonanni1 Abstract Background: Despite positive results from large phase III clinical trials proved that it is possible to prevent estrogen-responsive breast cancers with selective ... methodology and operational aspects of the clinical trial Trial Registration: (ClinicalTrials.gov Identifier: NCT01500577) Keywords: Clinical trial, Breast cancer prevention, Ductal lavage, Nimesulide, ... investigate in a chemoprevention trial in subjects at higher risk for ER negative breast cancer We are conducting a phase II, randomized, double blind, placebo controlled trial in 150 women at increased

Ngày tải lên: 05/11/2020, 07:59

... 18] Method Study design and objectives This trial (Trial No NCT02389400) is a prospective, single-center, single-arm, phase interventional clinical trial, the objective of the study was to explore ... be considered for the high incidence of hematological adverse effects Trial registration: Trial No NCT02389400 on Clinicaltrials.gov, registered on 10th Mar 2015 Keywords: Langerhans cell histiocytosis, ... arabinoside in newly diagnosed adult Langerhans cell histiocytosis: a prospective phase II interventional clinical trial Xiao Han†, Mingqi Ouyang†, Minghui Duan*, Wei Zhang, Tienan Zhu, Jian Li,

Ngày tải lên: 30/05/2020, 21:28

... multistage phase II cancer clinical trials J Biopharm Stat 2006;16(6):765–75 discussion 777-83 35 Jung SH Statistical issues for design and analysis of single-arm multi-stage phase II cancer clinical trials ... randomized phase II cancer clinical trials J Clin Oncol 2010;28(11):1936–41 54 Baey C, Le Deley MC Effect of a misspecification of response rates on type I and type II errors, in a phase II Simon ... enrolled in earlyphase clinical trials with a specific and strict set of eligibility criteria [38] Based on a systematic review of past experience, most phase II osteosarcoma trials are conducted

Ngày tải lên: 17/06/2020, 11:32

... associated complications such as portal vein tumor thrombosis, and refractoriness to TACE Two phase III clinical trials of sorafenib for advanced HCC showed significant efficacy in terms of overall survival ... not regarded as the standard of care for advanced HCC patients as no prospective randomized phase III trials have shown survival benefits in patients with advanced HCC Among responders, a better ... in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial Lancet Oncol 2009;10(1):25–34 15 Uka K, Aikata H, Takaki S, Miki

Ngày tải lên: 24/07/2020, 01:17

... 1/2 (ERK 1/2) in tumor tissue [26], suggesting a therapeutic benefit An ongoing, large Phase III randomized trial (NCIC CTG MA.32) in over 3,500 early stage breast cancer patients aims to determine ... planned for this Phase II trial Accrual, data collection, and any AEs will be monitored on a regular basis The final dataset will be available to all study investigators Discussion The trial was activated ... population at risk for multiple diseases Trial registration: ClinicalTrials.gov Identifier: NCT02028221 Registered on January 2, 2014 Grant #: 1R01CA172444-01A1 awarded on Sept 11, 2013 Keywords:

Ngày tải lên: 20/09/2020, 14:57

... significantly the treatment strategy in brain tumors, if in addition confirmed in a phase III trial Another important goal of this trial is to develop a strategy Oehlke et al BMC Cancer (2016) 16:769 Page ... (Continued from previous page) Trial registration: The GLIAA trial is registered with ClinicalTrials.gov (NCT01252459, registration date 02.12 2010), German Clinical Trials Registry (DRKS00000634, ... radiation oncology Methods/design Trial design and setting This is a prospective, open label randomized (allocation 1:1) two-arm parallel group phase II multi-centre trial designed to test for differences

Ngày tải lên: 20/09/2020, 18:11

... 10.1186/s12885-016- 2957 -y STUDY PROTOCOL Open Access Phase II clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of Head and Neck-V-CHANCE trial ... prognosis is particularly unfavorable for patients carrying the FcγRIIIa-158F/F genotype [42] Methods/Design V-CHANCE is a phase trial exploring the feasibility and the activity of VPA in combination ... will be correlated with polymorphisms of FcyRIIaH131R and the FcyRIIIa-V158F Statistical analysis The overall response rate (ORR) will be calculated with 95% confidence interval Time to progression,

Ngày tải lên: 20/09/2020, 18:51

... multi-institutional, phase II study investigates the efficacy of total neoadjuvant therapy (TNT) and selective non-operative management (NOM) in LARC Patients with MRI-staged Stage II or III rectal cancer ... conventional and diffusionweighted magnetic resonance imaging (DW-MRI) in Fig Trial schema MSKCC-based multi-institutional, Phase II trial schema underway to test the feasibility of incorporating a NOM ... Physicians Fig Nonoperative management trial contributors A map of the United States is shown to demonstrate the multiple institutions involved in this described Phase II trial determining the feasibility

Ngày tải lên: 22/09/2020, 23:35

... results of a GERCOR and GISCAD phase III trial J Clin Oncol 2005;23:3509–16 Colucci G, Labianca R, Di Costanzo F, Gebbia V, Cartenì G, Massidda B, et al Randomized phase III trial of gemcitabine plus ... in combination with gemcitabine demonstrating promise in phase II studies, but minimal impact on OS in subsequent phase III randomised trials Limited benefit has been demonstrated with the addition ... placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303) J Clin Oncol 2010;28:3 617? ??22 Page 12 of 12 32 Moore MJ, Goldstein D, Hamm J,

Ngày tải lên: 23/09/2020, 00:13

... being assessed in an adjuvant randomized phase II/ III study in breast cancer patients at high risk of recurrence (ICE II/ GBG 52 trial) In randomized phase III trials, capecitabine had a better toxicity ... gemcitabine transport [17] Preclinical studies have suggested a positive correlation between hENT1 gene expression and gemcitabine chemosensitivity [17] Data from phase II and phase III studies demonstrated ... (in stromal fibroblasts tumoral cells or in plasma) was confirmed in the phase III MPACT trial [40] The AFUGEM phase II trial is designed to assess the tolerability and efficacy of the sLV5FU2

Ngày tải lên: 28/09/2020, 01:41

... GI004/S1610 NCT02997228 Phase III 1L MMRd PFS Avelumab [33] NCT03150706 Phase II L+ MSI-H/MMRd POLE ORR Avelumab vs standard chemotherapy +/− targeted therapy [34] NCT03186326 Phase II 2L MSI PFS by ... bevacizumab were examined in phase I, II and III studies The safety of this combination resulted acceptable and AEs leading to treatment interruption were very low In a phase III study, 40% of pts treated ... therapy [26] CheckMate 9X8 NCT03414983 Phase II/ III 1L unselected PFS Nivolumab alone Nivolumab in combination with other drugs [27] CheckMate 142 NCT02060188 Phase II 1L MSI/MSS ORR by investigators

Ngày tải lên: 28/09/2020, 09:27

... patients (phase I /II, group 1) •Tumor/serum markers (phase I /II, both patient groups) Other secondary •Time to progression up to year after first MSC_apceth_101 administration (phase I /II) • Overall ... time periods:  For phase I and phase II, group 1: from Visit until Visit 15 If any radio- or chemotherapy starts before day 56 the reporting of AEs will be stopped  For phase II, group 2: from ... tolerability of MSC_apceth_101 in combination with GCV is sufficiently good to proceed to phase II In phase II, sixteen patients with adenocarcinoma from the digestive system will be enrolled in

Ngày tải lên: 30/09/2020, 12:37

... in a phase III trial Methods/design: We are conducting an international trial (France, Austria and Germany) consisting in parallel double-blind placebo-controlled randomized (1/1) phase II trials ... in each parallel phase II trials: prior exposure to pazopanib and countries Statistical assumption is based on recently published trials [14] Our trial is a comparative phase II trial, implying ... cancers (CRC) and GIST in two phase III trials Page of 10 The CORRECT study was an international, multicenter, randomized, double-blind, placebo-controlled Phase III study that enrolled 760 patients

Ngày tải lên: 30/09/2020, 13:05

... aged 18 – 79 years who have completed primary surgical treatment and have Stage IIb, IIc, IIIa (N1a, N2a) or IIIb (N1a, N2a) disease are eligible for randomisation 2:1 to active treatment or ... tumors thicker than mm or with nodal micro-metastases at diagnosis (AJCC Stages IIb, IIc, IIIa (N1a, N2a) and IIIb (N1a, N2a); Tables and 2) have a relatively poor prognosis with no known effective ... primary melanoma is not currently available Favorable outcomes of this phase II study will form the basis for a multi-centre phase III study to assess whether the addition of oral high-dose vitamin

Ngày tải lên: 30/09/2020, 14:38

... results from a phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with HER2-negative large resectable or stage II or III breast cancer ... and Michael P Lux1 Abstract Background: The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary ... of primary breast cancer tumors A randomized phase II trial was therefore conducted, with the primary objective being tumor response Methods The trial was conducted in accordance with the Helsinki

Ngày tải lên: 05/11/2020, 01:05

... controlled trial JAMA 2007, 297(3):267–277 10 Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K: A randomised phase III trial ... bias The selection and recording of the primary and secondary endpoints will allow further phase II or III studies in the future in case of promising results With the focus on a single center the ... Internal Medicine V Study design This is a single-arm, open phase II trial comparing the study data to historical controls Sponsor of the trial according to the GCP [39] guidelines and the German

Ngày tải lên: 05/11/2020, 01:33

... immunizations were supported by the addition of high-dose bolus IL-2 Methods Patients This phase II trial was an open label study of MVA-5T4 vaccine in patients with metastatic clear cell or ... region Study design A dose of × 108 pfu (1 ml) MVA-5T4 was established as safe in a Phase I trial [11] In this trial, the first dose was given by intramuscular injection alone and booster vaccination ... tumor antigen 5T4 (TroVax) induces immune responses which correlate with disease control: a phase I /II trial Clin Cancer Res 2006, 12:3416-3424 Harrop R, Ryan MG, Myers KA, Redchenko I, Kingsman...

Ngày tải lên: 18/06/2014, 15:20

... Human Use (ICH)-Good Clinical Practice (GCP)-registered phase I /II clinical trial of rh-HGF As this application is the first clinical trial to administer rh-HGF to humans, we performed additional ... to evaluate renal involvement, including serum creatinine and histological findings A phase I /II clinical trial for patients with acute liver failure Overview This single-arm, open-labeled, and ... recombinant human hepatocyte growth factor (rh-HGF) in patients with fulminant hepatitis: a phase I /II clinical trial, following preclinical studies to ensure safety Journal of Translational Medicine...

Ngày tải lên: 18/06/2014, 19:20