Phase II trial of bevacizumab in combination with temozolomide and regional radiation therapy for up-front treatment of patients with newly diagnosed glioblastoma multiforme

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2000-2000 ◽  
Author(s):  
A. Lai ◽  
P. Nghiemphu ◽  
R. Green ◽  
L. Spier ◽  
S. Peak ◽  
...  
Keyword(s):  
Phase Ii ◽  
Outcome Measure ◽  
Phase Ii Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Secondary Outcome Measure ◽  
Newly Diagnosed ◽  
Standard Regimen ◽  
Safety And Efficacy ◽  
Wound Breakdown

2000 Background: Bevacizumab (BV) is a humanized monoclonal antibody directed against the vascular endothelial growth factor (VEGF). Based on the promising activity of BV in the treatment of recurrent glioblastoma, we are conducting a phase II trial to determine whether up-front treatment of newly diagnosed GBM with BV may be more advantageous than withholding BV until recurrence. In this trial, we evaluate the safety and efficacy of BV combined with standard of care radiation (RT) and temozolomide (TMZ) and radiation (RT) for newly-diagnosed GBM. Methods: This is a phase II trial with a 10-patient pilot and 60-patient expansion phases. Newly-diagnosed GBM patients with no prior treatments are eligible. Primary outcome measure is overall survival; the secondary outcome measure is TTP and 12-month survival. Therapy began between 3–5 weeks of surgery with BV (10 mg/kg every 2 weeks), TMZ (75 mg/m2 daily), and external beam RT (30 x 200 Gy) on the same day. After completion of radiation, patients are then placed on a maintenance phase of BV (10mg/kg every 2 weeks) and TMZ (150–200 mg/m2 5 out of every 28 days) until progression or 24 months in which patients are then maintained on BV only. Results: 70 of 70 projected GBM patients have been enrolled between August 2006 and November 2008 at UCLA and Kaiser Permanente (KP) (Northern and Southern California). All patients had resections to ensure that frozen tissue (>200mg) was collected. The median age was 57.4 years (range 31–75). MGMT methylation analysis has been performed on 52/70 patients with ∼40% showing methylation. Severe adverse events to date have included ischemic stroke, pulmonary embolus, wound breakdown, GI bleeding/perforation, and renal dysfunction. Isolated cases of retinal detachment and optic neuropathy have also been observed. As of now, 35/70 patients are off study (26 due to progression and 9 due to SAE). Preliminary TTP by Kaplan-Meier analysis is promising compared to that of a UCLA/KP control group of patients that received the conventional RT/TMZ regimen. Conclusions: Addition of BV to the standard regimen of TMZ and RT for newly-diagnosed GBM is well-tolerated and shows promising efficacy. More detailed analysis of safety and efficacy will presented. [Table: see text]

Clinical Effects of Sensor AR40E Intraocular Lenses in Cataract Patients with Prominent Myopia

2020 ◽  
Vol 12 (4) ◽  
pp. 461-466
Author(s):  
Wenying Wang ◽  
Zhixue Wang ◽  
Yu Liu ◽  
Yuanyuan Zou ◽  
Xiangning Ji ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Intraocular Lens ◽  
Group Treatment ◽  
Outcome Measure ◽  
Acupuncture Group ◽  
Intraocular Lenses ◽  
Secondary Outcome ◽  
Control Group ◽  
Secondary Outcome Measure ◽  
Clinical Effects

Cataracts are a complex group of eye disorders. Many studies suggest that blood circulation around the eyes, and a rise in intraocular pressure play important roles in glaucoma. Sensor AR40E artificial crystalline bodies can adjust intraocular pressure, improve activity in the optic nerve and increase blood flow to the eye fundus. BL1 can transport Yin and Yang. We designed a randomized, military blind, controlled clinical trial: Control group: (1) A Sensor only AR40E intraocular lens was applied to the skin of Qingming and retrobulbar acupoints on the rainy side, twice per week for 20 min every time, for two consecutive weeks; (2) acupuncture group: treatment was same as for the control group, but the eye was needled into Jingming and retrobulbar acupoints to achieve Qi; (3) Sensor AR40E intraocular lens group: treatment was the same as that for the acupuncture group, the main outcome measure was the change of intraocular pressure and the secondary outcome measure is the score change of WHOQOL ref (Taiwan version). Beneficial outcomes were realized in the right and left eye acupuncture groups and the Sensor AR40E intraocular lens group.

scholarly journals A PROSPECTIVE OBSERVATIONAL STUDY COMPARING CLINICAL OUTCOME OF IUGR NEONATES WITH NORMAL AND ABNORMAL UMBILICAL ARTERY FLOW DOPPLER

2020 ◽  
pp. 1-3
Author(s):  
Aarti Panchal ◽  
Sucheta Munshi ◽  
Halak Chauhan
Keyword(s):  
Umbilical Artery ◽  
Outcome Measure ◽  
Perinatal Asphyxia ◽  
Secondary Outcome ◽  
Control Group ◽  
Case Group ◽  
Secondary Outcome Measure ◽  
Perinatal Complications ◽  
Umbilical Artery Doppler ◽  
Artery Flow

Background: Intrauterine growth restriction (IUGR) is one of the causes of perinatal mortality and morbidity which affects approximately 9.65% of pregnancies worldwide. Doppler indices from the fetal circulation can reliably predict adverse perinatal outcome. Aims &objectives: To compare perinatal complications and outcome between term and preterm IUGR neonates having normal and abnormal umbilical artery flow Doppler. Methodology: 140 IUGR Neonates with abnormal and normal antenatal umbilical artery Doppler scan admitted in NICU of Civil Hospital, Ahmedabad were included in the study. Amongst them 52 were preterm and 88 were term neonates. Study was conducted between October 2019 to December 2019. Primary outcome measure is neonatal mortality and secondary outcome measure is neonatal morbidities like perinatal asphyxia, hypoglycemia, NEC, hyperbilirubinemia etc. Results: Amongst140 IUGR neonates Preterm were more in case group 36(51.4%) compared to control group 16(22.8 %.) Hypoglycaemia and NEC was observed more in preterm 19 (36.5%) and 14(26.9%) compared to 16(18.2%) and 11(12.5%) in term respectively. Birth asphyxia was observed more in term 26(29.5%) than preterm 7(13.5%). At birth perinatal asphyxia was observed more in case group, 27 out of 70 (38.5%), as compared to 6 out of 70 (8.5%) in control group (P <0.05). Hypoglycemia and NEC was noticed in 30(42.8%) and 24(34.2%) neonates in case group, as compared to 5(7.1%) and 2(2.8%) neonates in control group respectively. (P < 0.05) Conclusion: Neonates with abnormal Umbilical Artery Doppler flow are at increased risk of perinatal complications and needs extra care during this period.

scholarly journals To compare the perinatal outcome of IUGR infants with abnormal and normal antenatal umbilical artery Doppler flow in the immediate neonatal period

2017 ◽  
Vol 6 (4) ◽  
pp. 1449 ◽  
Author(s):  
Shivaprasad B. ◽  
Devendrakumar Sharma
Keyword(s):  
Perinatal Outcome ◽  
Umbilical Artery ◽  
Outcome Measure ◽  
Perinatal Asphyxia ◽  
Secondary Outcome ◽  
Control Group ◽  
Case Group ◽  
Secondary Outcome Measure ◽  
Doppler Flow ◽  
Umbilical Artery Doppler

Background: Intrauterine growth restriction (IUGR) is one of the cause of perinatal mortality and morbidity and affects approximately 7-15% of worldwide pregnancies. IUGR is the failure of the fetus to achieve intrinsic growth potential, due to disorders and diseases in the feto–placental–maternal unit. Doppler indices from the fetal circulation can reliably predict adverse perinatal outcome. Aim of the study was to determine perinatal outcome of IUGR infants with abnormal antenatal umbilical artery Doppler flow versus IUGR infants with normal Doppler flow.Methods: All Preterm and term IUGR infants with abnormal and normal antenatal umbilical artery Doppler scan admitted in NICU of St Martha’s Hospital were included in the study. 30 in each group with total sample size of 60. Study was conducted from March 2015 to February 2016. Primary outcome measure will be neonatal mortality and secondary outcome measure will be neonatal morbidities like perinatal asphyxia, hypoglycemia, NEC, polycythemia, sepsis, hyperbilirubinemia etc.Results: IUGR infants with abnormal antenatal umbilical artery Doppler scan were included as cases and those with normal antenatal umbilical artery Doppler scan as control. At birth resuscitation rate and therefore perinatal asphyxia was observed more in case group, 11 out of 30 (36.6%), compared to 1 out of 30 (3.3%) in control group, statistically significant (P <0.05). Hypoglycemia was noticed in 19 infants in case group (63.3%) compared to 2 infants (6.6%) in control group, statistically significant. NEC, polycythemia, sepsis was noticed more in case group, but statistically not significant.Conclusions: Infants with abnormal antenatal Doppler flow are at increased risk of perinatal complications than infants with normal antenatal umbilical artery Doppler and needs extra care during this period.

scholarly journals ACTR-69. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi29-vi29
Author(s):  
Garni Barkhoudarian ◽  
Nicholas Blondin ◽  
Sajeel Chowdhary ◽  
Ekokobe Fonkem ◽  
Brian Vaillant ◽  
...  
Keyword(s):  
Adverse Events ◽  
Outcome Measure ◽  
Progression Free Survival ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Newly Diagnosed ◽  
Open Label ◽  
Serious Adverse Events ◽  
Radio Frequency Energy

Abstract BACKGROUND The EMulate Therapeutics Voyager system is an investigational non-sterile, non-invasive, non-thermal, non-ionizing, portable, home-use medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of brain cancer. METHODS This open-label, multi-center study (NAT-109) enrolled adults newly diagnosed with GBM. Following surgical debulking, patients were enrolled and treated concurrently with temozolomide, radiotherapy, and Voyager. The objective of the study is to assess if the Voyager is a safe and feasible treatment for newly diagnosed GBM when combined with standard of care. The primary outcome measure is safety, assessed by the incidence and evaluation of any adverse events (AEs) associated with the Voyager. The secondary outcome measure is clinical utility, assessed by progression-free survival and overall survival. RESULTS Enrollment is closed, and treatment and long-term follow-up is ongoing. A total of 37 patients were enrolled and treated. 27 patients reported 282 AEs, none of which required withdrawal from the study. One AE was reported as probably related to the device - i.e., mild dysesthesia, which resolved without interruption or cessation of treatment with the device. 15 patients reported 28 SAEs, and none were reported as related to the device. 56% of patients were progression-free at 6 months, and 43% were progression-free at 12 months. 89% of patients were still alive after 6 months, 71% were still alive after 12 months. CONCLUSIONS The Voyager system appears to be safe and feasible for the treatment of newly diagnosed GBM. Given that therapy is delivered non-invasively and no device-related serious adverse events were reported, further prospective study of the investigational device is planned.

scholarly journals Double blinded randomized placebo-controlled comparative study between sucralfate ointment and lidocaine ointment after Milligan Morgan hemorrhoidectomy

2017 ◽  
Vol 4 (12) ◽  
pp. 3822
Author(s):  
Yahia Alkhateep ◽  
Abdelmieniem Fareed
Keyword(s):  
Wound Healing ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Secondary Outcome Measure ◽  
Lidocaine Group ◽  
Significant Difference ◽  
Double Blinded

Background: Post haemorrhoidectomy pain and delayed wound healing are the most annoying drawbacks to the patients and the surgeons. Topical application of sucralfate or lidocaine may help in reducing postoperative pain and promoting wound healing after Milligan Morgan hemorrhoidectomy.Methods: This study was designed as a single-center double blinded randomized placebo controlled trial at the Department of general Surgery Menoufia University, immediately after Milligan Morgan Hemorrhoidectomy, a total of 150 patients were randomly assigned to receive either 10% Sucralfate ointment, 5% lidocaine ointment or placebo ointment (control group). The primary outcome measure was pain intensity measured by a visual analogue scale at different time points after hemorrhoidectomy and the secondary outcome measure was wound healing.Results: There was no significant difference in age, gender, and number of excised hemorrhoid piles between the two groups. At the 1st ,3rd and 7th days after surgery pain intensity was significantly lower in sucralfate group (4.18±0.82, 3.92±0.72, 3.56±0.67) when compared to lidocaine group (5.06±1.11, 4.70±0.84, 3.93±0.75) and placebo group (6.17±1.26, 5.42±0.98, 4.55±0.84). At the 21st and 28th days no significant difference in pain intensity between groups (p > 0.05) with better wound healing in sucralfate group (P<0.05).Conclusions: Sucralfate was able to reduce the acute postoperative pain and improve wound healing after hemorrhoidectomy, local anesthetic lidocaine could help in pain control but without effect on healing.

scholarly journals The Role of Intra-Operative Wound Irrigation with Normal Saline in Reduction of Surgical Site Infection in Gynecological Surgeries

2021 ◽  
Vol 29 (02) ◽  
pp. 115-118
Author(s):  
Uzma Urooj ◽  
Sumaira Khan ◽  
Rabia Imran
Keyword(s):  
Normal Saline ◽  
Outcome Measure ◽  
Secondary Outcome ◽  
Military Hospital ◽  
Control Group ◽  
Skin Closure ◽  
Secondary Outcome Measure ◽  
Wound Irrigation ◽  
Cohort Group ◽  
Operative Wound

Objective: To evaluate the efficacy of intra-operative wound irrigation with normal saline in reducing surgical site infections in gynaecological surgeries. Methods: It is a prospective cohort study carried out at Obstetrics and Gynaecology Department, Pak-Emirates Military Hospital, Rawalpindi from 1st November 2019 to 30th April 2020. A total of 400 patients undergoing abdominal surgery for gynecological reasons were recruited by consecutive non-probability technique. Patients with known comorbidities were excluded. Participants of study were allocated cohort and control groups at the end of the surgery after closing the abdominal fascia. In cohort group, the subcutaneous soft tissue was irrigated with 1000 ml of Normal saline solution before skin closure and sterile dressing. No intra-operative wound irrigation was performed in the control group. The primary and secondary endpoint measures (SSI up to 10th Post-Operative day) and (SSI up to 30th Post-Operative day) respectively, were assessed clinically. Results: The study included 400 patients, with 200 in the cohort group and 200 in the control group with Mean Age of (Mean ± SD) 33.6±8.1 years. Majority of the patients had Pre-Op Hemoglobin of >11 g/dl (216)54%. Most common surgeries were Caesarean section (324)81% and Hysterectomy (40)10%. Maximum surgeries were performed between 30-30 min (312)78% with mean hospital stay of (Mean ± SD) 2.9±0.5 days. Analysis of the results showed that Intra-operative wound irrigation with normal saline significantly lesser rate of postoperative SSIs in comparison to no irrigation at both primary outcome measure that was SSI at 10th Post-operative day (POD)(RR=0.417, 95 % CI [0.15;1.161]) and secondary outcome measure that was SSI at 30th POD(RR=0.286, 95 % CI [0.060;1.359]). Conclusion: Intra-operative wound irrigation with Normal Saline decreases the risk of SSI by 58.3% (AR) at 10thPOD and by 71.4% (AR) at 30th POD in otherwise healthy women with no comorbidities.

scholarly journals Non-surgical oral hygiene interventions on disease activity of Rheumatoid arthritis patients with periodontitis: A randomized controlled trial

2020 ◽  
Vol 14 (1) ◽  
pp. 26-36
Author(s):  
William Buwembo ◽  
Ian Guyton Munabi ◽  
Mark Kaddumukasa ◽  
Haruna Kiryowa ◽  
Muhammad Mbabali ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Oral Hygiene ◽  
Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Secondary Outcome Measure ◽  
Das 28 ◽  
Periodontal Index

Background . Periodontitis and rheumatoid arthritis have similar epidemiology and pathophysiology. Understanding the interaction between these two diseases is vital in our settings. We set out to assess the effect of oral hygiene interventions on disease activity of rheumatoid arthritis patients with periodontitis in Kampala, Uganda. Methods. Fifty-eight patients attending an arthritis clinic with rheumatoid arthritis and periodontitis were randomly assigned to either an intervention group or a control group. Patients diagnosed with rheumatoid arthritis at least two years before, who were on the same medication, dose, or formulation for RA treatment during the preceding three months, were included. The patients were >18 years of age, would be available for all the study visits in the next six months, had at least six natural teeth, had periodontal disease classified as Dutch Periodontal Index (DPSI) >3 and provided written informed consent. Those who had a chronic disorder requiring chronic or intermittent use of antibiotics, were pregnant, were lactating, or had intent to become pregnant were excluded. The primary outcome measure was a change in Disease Activity Score of 28 Joints (DAS28 score) in two 3-month follow-up periods after the intervention. The secondary outcome measure was a change in periodontal status. Results. There was a statistically significant improvement in the DAS-28 score in both the intervention and control arms during the follow-up period (P<0.01). The participants carrying more than one bacterial species had worse DAS-28 scores. Conclusion. Oral hygiene interventions given to RA patients could drastically improve their RA treatment outcomes, especially in resource-limited settings.

Phase II trial of bevacizumab and temozolomide for upfront treatment of elderly patients with newly diagnosed glioblastoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2012-2012
Author(s):  
Phioanh Leia Nghiemphu ◽  
Hye Hyun Bahng ◽  
Albert Lai ◽  
Nadia Faiq ◽  
William H. Yong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Adverse Events ◽  
Elderly Patients ◽  
Tumor Progression ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Newly Diagnosed ◽  
Safety And Efficacy

2012 Background: Randomized clinical trials in newly diagnosed, elderly GBM patients have shown that treatment with temozolomide chemotherapy is at least equivalent to treatment with radiotherapy. Glioblastoma in elderly patients may also have high angiogenic activities. Bevacizumab is an antiangiogenic agent, a humanized monoclonal antibody directed against the vascular endothelial growth factor. We conduct a clinical trial of temozolomide and bevacizumab to evaluate the safety and efficacy of this combination in the treatment of elderly patients with newly diagnosed GBM, good performance status, and willing to forgo upfront treatment with radiation therapy. Methods: This is a phase II trial of newly diagnosed GBM patients age ≥70 with no prior treatments other than surgery and Karnofsky Performance Status (KPS) ≥60. Patients receive treatments 4-6 weeks after surgery with bevacizumab (10mg/kg every 2 weeks) and temozolomide (150-200 mg/m2 for 5 days out of 28 days, up to 12 cycles) until tumor progression. Primary outcome measures are overall survival and safety evaluations. Results: From June 2010 to January 2016, 50 GBM patients enrolled in this study. To date, all patients have tumor progression and 3 are still alive. The median age is 75 (range 70 - 87), and median KPS is 80 (range 60-100). 15 patients have a gross total resection. 26 out of 49 patients with tissues available for evaluation have methylation of the MGMT promoter, and no patient has IDH-1 mutation. Median overall survival is 12.3 months (14.8 months for those with methylation of MGMT, 10.0 months for unmethylated MGMT). Serious adverse events related to treatments include wound healing problems (2), CNS hemorrhage (3), pulmonary embolism (4), and bowel perforation (1). Serious hematological adverse events include thrombocytopenia (3) and neutropenia (5). Conclusions: For patients with newly diagnosed GBM age ≥70, KPS ≥60, treatment with temozolomide and bevacizumab may show promising survival benefits and have tolerable side effects. More detailed safety and efficacy analysis will be presented. Clinical trial information: NCT01149850.

Impact of Guideline Implementation on Patient Care: a Cluster RCT

2009 ◽  
Vol 89 (1) ◽  
pp. 71-76 ◽  
Author(s):  
T.G. Mettes ◽  
W.J.M. van der Sanden ◽  
E. Bronkhorst ◽  
R.P.T.M. Grol ◽  
M. Wensing ◽  
...  
Keyword(s):  
Patient Care ◽  
Outcome Measure ◽  
Guideline Implementation ◽  
Intervention Group ◽  
Implementation Strategies ◽  
Secondary Outcome ◽  
Control Group ◽  
Secondary Outcome Measure ◽  
Relevant Effect ◽  
Dental Practitioners

In Western European countries, dentists use standardized procedures, rather than individualized risk assessment, for routine oral examinations. The predictive hypothesis was that guideline implementation strategies based on multifaceted interventions would be more effective in patient care than the dissemination of guidelines only. A cluster-randomized trial was conducted, with groups of general dental practitioners (GDPs) as the unit of randomization. Patients were clustered within practices and prospectively enrolled in the trial. Patient data were collected from registration forms. The primary outcome measure was guideline-adherent recall assignment, and a secondary outcome measure was guideline-adherent bitewing frequency. The interventions consisted of online training, guideline dissemination, and educational sessions. For low-risk patients, guideline-adherent recall increased in the intervention group (+8%), which differed from the control group (−6.1%) (p = 0.01). Guideline-adherent bitewings showed mixed results. We conclude that multifaceted intervention had a moderate but relevant effect on the performance of GDPs, which is consistent with other findings in primary care.

scholarly journals Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e025877 ◽  
Author(s):  
Caroline Brard ◽  
Sophie Piperno-Neumann ◽  
Jessy Delaye ◽  
Laurence Brugières ◽  
Lisa V Hampson ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Postoperative Chemotherapy ◽  
Control Group ◽  
Newly Diagnosed ◽  
Open Label ◽  
Logrank Test ◽  
Open Label Phase ◽  
The Impact

IntroductionThe controversial results on the mifamurtide efficacy associated with chemotherapy, issued from the American INT-0133-study, in localised osteosarcomas, and the underpowered analysis performed separately in metastatic patients, should be clarified to homogenise international use of this promising drug. The European Commission has granted a marketing authorisation to mifamurtide combined with postoperative chemotherapy in localised osteosarcomas but not in metastatic patients, while the Food and Drug Administration (FDA) has denied this authorisation.Methods and analysisSarcome-13/OS2016 trial is a multicentre randomised open-label phase II trial evaluating the survival benefit of mifamurtide administered during 36 weeks in combination with postoperative chemotherapy versus chemotherapy alone, in patients >2 and ≤50 years with newly diagnosed high-risk localised or metastatic osteosarcoma. The main objective is to evaluate the impact on event-free survival (EFS) of mifamurtide on intention-to-treat population. The secondary objectives are to evaluate the impact of mifamurtide on overall survival, to evaluate the feasibility and toxicity of the planned treatment, to correlate biology/immunology with the mifamurtide efficacy/toxicity. With a total of 126 enrolled patients and 51 events, the power is 80% if mifamurtide is associated with an 18% improvement of the 3-year EFS (52%vs70%, equivalent to an HR=0.55), with a one-sided logrank test alpha=10%. As relevant historical data are available (aggregate treatment effect from the INT-0133 trial and individual data from the control group of the Sarcome-09/OS2006 trial), a Bayesian analysis is also planned.Ethics and disseminationThis study was approved by the ‘Comité de Protection des Personnes Ile de France I’ (12/06/2018), complies with the Declaration of Helsinki and French laws and regulations, and follows the International Conference on Harmonisation E6 Guideline for Good Clinical Practice. The trial results, even if they are inconclusive, as well as biological ancillary studies will be presented at appropriate international congresses and published in international peer-review journals.Trial registration numberEudraCT 2017-001165-24,NCT03643133

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