CTNI-56. A PHASE II CLINICAL TRIAL USING ACCELERATOR-BASED BNCT SYSTEM FOR REFRACTORY RECURRENT HIGH-GRADE MENINGIOMA

Abstract BACKGROUND Boron neutron capture therapy (BNCT) is tumor-selective particle radiation. Recently accelerator-based neutron sources (ABNS) have been developed for clinical trials to obtain on-label use, i.e. new drug approval for malignant gliomas. Recently Japanese regulatory authority has just given this permission for H&N cancers. Recurrent high-grade meningiomas (HGM) are difficult to control. We have applied reactor-based BNCT for 46 cases of refractory HGM. All cases showed good tumor shrinkage with good local control. PURPOSES Based on these situations, we proposed “A phase II clinical trial using accelerator-based BNCT system for refractory recurrent HGM” for AMED in Japan which is similar to NIH in USA. This proposal was successfully accepted. DESIGN We prepared 2 study groups, BNCT test treatment group and control best supportive care group, for RCT. PFS and OS were set-up as primary and secondary endpoints, respectively. Rescue BNCT is allowed for control group patients, if they showed PD during observation. Modified Macdonald criteria is adopted for assessment. Hypothesized PFS of treatment group and control group was 5 months and 24 months, respectively. The trial started in August 2019. METHODS Twelve BNCT and 6 control subjects will be included. Patients’ eligibility criteria is recurrent HGM after some radiotherapy. Cyclotron-based ABNS system is used for neutron source. Neutron-irradiation time is determined not to exceed to 7.5 Gy-Eq for scalp dose which was referencing preceding phase I trial for malignant gliomas. PROGRESS As of April 2020, 4 subjects were included, 3 for BNCT treatment group, 1 for control best supportive care group. The control subject showed PD during one month observation and rescue treatment showed PR. Treatment group 3 cases showed more than SD. CONCLUSION We started this RCT and will introduce the interim report of this clinical trial in the meeting.

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RTID-07. AN INVESTIGATOR-LEAD PHASE II CLINICAL TRIAL OF ACCELERATOR-BASED BNCT FOR REFRACTORY AND RECURRENT HIGH-GRADE MENINGIOMA

Neuro-Oncology ◽

10.1093/neuonc/noab196.769 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi194-vi194

Author(s):

Shin-Ichi Miyatake ◽

Shinji Kawabata ◽

Satoshi Takai ◽

Masahiko Wanibuchi

Keyword(s):

Clinical Trial ◽

Treatment Group ◽

Supportive Care ◽

Phase Ii ◽

Best Supportive Care ◽

Phase Ii Clinical Trial ◽

Care Group ◽

High Grade ◽

Neutron Sources ◽

Control Subjects

Abstract BACKGROUD Boron neutron capture therapy (BNCT) is tumor-selective particle radiation. We applied this unique technique and achieved excellent clinical results for recurrent and refractory high-grade meningiomas (HGM) using reactor neutron sources (Neuro-Oncology, in press, doi:10.1093/neuonc/noab108). Recently accelerator-based neutron sources (ABNS) was approved for medical device in Japan for refractory H&N cancers. PURPOSES Based on these situations, we proposed “A phase II clinical trial using accelerator-based BNCT system for refractory recurrent HGM” for AMED in Japan which is similar to NIH in USA. This proposal was successfully accepted. DESIGN We prepared 2 study groups, BNCT test treatment group and control best supportive care group, for RCT. PFS and OS were set-up as primary and secondary endpoints, respectively. Rescue BNCT is allowed for control group patients, if they showed PD during observation. The trial started in August 2019. METHODS Twelve BNCT and 6 control subjects will be included. Patients’ eligibility criteria is recurrent HGM after some radiotherapy. Cyclotron-based ABNS system is used for neutron source. Neutron-irradiation time is determined not to exceed to 7.5 Gy-Eq for scalp dose which was referencing preceding phase I trial for malignant gliomas. PROGRESS As of March 2021, 13 subjects were included, 9 for BNCT treatment group, 4 for control best supportive care group. All 4 control subjects showed PD during 2 months while 8 out of 9 subjects showed SD or PR during observation period and there is a statistical significance in both groups, by Log-rank and Wilcoxon analyses with p=0.0012 and 0.0020, respectively. CONCLUSION We started this RCT and will introduce the interim report of this clinical trial in the meeting. At the SNO meeting we will present further detail of this trial.

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Lower-Limb Lymphedema and Vulval Cancer: Feasibility of Prophylactic Compression Garments and Validation of Leg Volume Measurement

International Journal of Gynecological Cancer ◽

10.1111/igc.0b013e3181a8446a ◽

2009 ◽

Vol 19 (9) ◽

pp. 1649-1654 ◽

Cited By ~ 31

Author(s):

Saladin Sawan ◽

Rachel Mugnai ◽

Alberto de Barros Lopes ◽

Andrew Hughes ◽

Richard J. Edmondson

Keyword(s):

Treatment Group ◽

Supportive Care ◽

Volume Measurement ◽

Best Supportive Care ◽

Alternative Methods ◽

Control Group ◽

Intraobserver Variability ◽

Life Questionnaire ◽

Compression Stockings ◽

Vulval Cancer

Objectives:Leg lymphedema remains a significant health problem after treatment of vulval cancer. This pilot study explored the feasibility of conducting a larger trial to investigate whether the early use of compression stockings is effective in preventing leg lymphedema.Methods:Fourteen patients undergoing inguinofemoral lymphadenectomy for vulval cancer were randomized to either best supportive care or best supportive care plus the use of graduated compression stockings for 6 months.Results:Six of 7 patients in the treatment group complied with the study protocol. The incidence of clinically significant lymphedema was not different between both groups; however, there was a greater increase in mean leg volume in the control group (953 vs 607 mL, P = 0.010). Furthermore, patients in the treatment group showed better performance as judged by leg symptoms (P = 0.031, at 3 months) and clinical examination (P = 0.039 at 4 weeks and P = 0.004 at 6 months). There was no difference in the incidence of groin wound dehiscence, infection, or lymphocyst formation. We detected no difference between both groups' scores when using a validated quality-of-life questionnaire. Intraobserver and interobserver variabilities of leg-volume measurement technique were investigated using the principles of repeatability and reproducibility statistics. Intraobserver variability was estimated at 270 mL, whereas interobserver variability was 1000 mL.Conclusions:The prophylactic use of stockings in this population is feasible, and further larger studies are justified to investigate its role in reducing the incidence of leg lymphedema. The design of these studies should take into account the observer-related variability in measuring leg volume or consider alternative methods.

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A randomized, double-blind, parallel-group, placebo-controlled, multicenter, phase II clinical study of famitinib in the treatment of advanced metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.513 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 513-513 ◽

Cited By ~ 8

Author(s):

Rui-hua Xu ◽

Lin Shen ◽

Keming Wang ◽

Gang Wu ◽

Chunmei Shi ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Study ◽

Treatment Group ◽

Adverse Events ◽

Phase Ii ◽

Advanced Colorectal Cancer ◽

Control Group ◽

Double Blind ◽

Phase Ii Clinical Study ◽

And Control

513 Background: Colorectal cancer (CRC) is the third most frequently diagnosed cancer and is the fifth leading cause of cancer death in China. No standard care is available for patients with advanced CRC who failed the second-line treatment. Famitinib is a small-molecular, multi-target receptor tyrosine kinase inhibitor which primarily acts against angiogenesis. This phase II study was designed to evaluate the efficacy and safety of famitinib in the treatment of advanced colorectal cancer. Methods: This is a multi-center, randomized, double-blind, placebo-controlled, phase II clinical study (ClinicalTrials.gov Registration No.: NCT01762293). Totally 154 patients with advanced colorectal cancer who failed second or later-line treatments were randomized in a 2:1 ratio to receive either famitinib or placebo at 25 mg each day in each treatment cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL) and safety. The statistical analyses of endpoints were using intent-to-treat population. Results: Of 154 patients randomized, the mPFS was 2.8 and 1.5 months in the treatment group and control group, respectively (p=0.0034; HR=0.58). The ORR was 2.02% and 0.00% (p=0.54) and the DCR was 57.58% and 30.91% (p=0.0023) in the treatment group and control group, respectively. Analysis of OS data is ongoing. The frequently reported adverse events (AEs) include neutropenia, thrombocytopenia, hypertension, proteinuria, and hand-foot syndrome and were most grade 1/2. The incidences of serious adverse events (SAEs) for the famitinib and placebo groups were 11.11% and 9.09%, respectively (p=0.7884). Overall, famitinib was well tolerated and toxicities were manageable. Conclusions: Famitinib improved the PFS in patients with advanced metastatic colorectal cancer resulting in higher ORR and DCR in the treatment group with good safety and tolerability. Clinical trial information: NCT01762293.

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Comparison of the Effects of Maternal Supportive Care and Acupressure (BL32 Acupoint) on Pregnant Women’s Pain Intensity and Delivery Outcome

Journal of Pregnancy ◽

10.1155/2014/129208 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 10

Author(s):

Marzieh Akbarzadeh ◽

Zahra Masoudi ◽

Mohammad Javad Hadianfard ◽

Maryam Kasraeian ◽

Najaf Zare

Keyword(s):

Supportive Care ◽

Pain Intensity ◽

Care Group ◽

Control Group ◽

Control Groups ◽

Delivery Outcome ◽

Effective Strategies ◽

Significant Difference ◽

The Difference ◽

And Control

Delivery is considered as one of the most painful experiences of women’s life. The present study aimed to compare the effects of supportive care and acupressure on the pregnant women’s pain intensity and delivery outcome. In this experimental study, 150 pregnant women were randomly divided into supportive care, acupressure, and control groups. The intensity of pain was measured using Visual Analogue Scale (VAS). The supportive care group received both physical and emotional cares. In the acupressure group, on the other hand, BL32 acupoint was pressed during the contractions. Then, the data were analyzed using descriptive and inferential statistics. The results revealed significant difference among the three groups regarding the intensity of pain after the intervention (P<0.001). Besides, the highest rate of natural vaginal delivery was observed in the supportive care group (94%) and the acupressure group (92%), while the highest rate of cesarean delivery was related to the control group (40%) and the difference was statistically significant (P<0.001). The results showed that maternal supportive care and acupressure during labor reduced the intensity of pain and improved the delivery outcomes. Therefore, these methods can be introduced to the medical team as effective strategies for decreasing delivery pain. This trial is registered with the Iranian Registry of Clinical Trial CodeIRCT2014011011706N5.

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Perbandingan Efek Suplementasi Tablet Tambah Darah Dengan Dan Tanpa Vitamin C Terhadap Kadar Hemoglobin Pada Ibu Hamil Dengan Usiakehamilan 16-32 Minggu Di Desa Keniten Kecamatan Mojo Kabupaten Kediri

Jurnal Ilmu Kesehatan ◽

10.32831/jik.v3i1.49 ◽

2017 ◽

Vol 3 (1) ◽

pp. 76

Author(s):

Siti Asiyah ◽

Dwi Estuning Rahayu ◽

Wiranti Dwi Novita Isnaeni

Keyword(s):

Treatment Group ◽

Vitamin C ◽

Gestational Age ◽

Group Treatment ◽

Sampling Technique ◽

Hemoglobin Level ◽

The Body ◽

Control Group ◽

Fetal Organ ◽

And Control

The needed of Iron Tablet in pregnancy was increase than mother who not pregnant. That cause of high metabolism at the pregnancy for formed of fetal organ and energy. One of effort for prevent anemia in mother pregnant with giving the Iron tablet and vitamin c. The reason of this research in 4 June – 11 July 2014 is for compare the effect of iron tablet suplementation with and without vitamin C toward Hemoglobin level in mother pregnant With Gestational Age Of 16-32 Weeks In Desa Keniten Kecamatan Mojo Kabupaten Kediri. This research method using comparative analytical. Research design type of Quasy Eksperiment that have treatment group and control group. Treatment group will giving by Iron tablet and 100 mg vitamin C, and control group just giving by iron tablet during 21 days. Population in this research are all of mother pregnant with Gestational Age Of 16-32 Weeks with Sampling technique is cluster random sampling is 29 mother pregnant. Comparison analysis of iron tablet suplementation effect with and without vitamin C toward Hemoglobin level in mother pregnant With Gestational Age Of 16-32 Weeks, data analysis using Mann Whitney U-test and the calculated U value (44,5) less than U-table (51). So there was difference of iron tablet suplementation effect with and without vitamin C toward Hemoglobin level in mother pregnant With Gestational Age Of 16-32 Weeks Therefore, the addition of vitamin C on iron intake is needed to increase the uptake of iron tablets. When the amount of iron uptake increases, the reserves of iron in the body will also increase, so as to prevent anemia in pregnant women; Keywords : Iron Tablet (Fe), Vitamin C, Hemoglobin level, Mother Pregnant

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Outcome of lymph node tuberculosis management with conventional treatment with and without prednisolone

Tropical Doctor ◽

10.1177/0049475520984745 ◽

2021 ◽

pp. 004947552098474

Author(s):

Arjuman Sharmin ◽

Ali Hossain ◽

Nazmul Islam ◽

Zakir H Sarker ◽

Sheikh S Hossain ◽

...

Keyword(s):

Clinical Trial ◽

Lymph Node ◽

Complete Resolution ◽

Conventional Treatment ◽

Symptomatic Improvement ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Lymph Node Tuberculosis ◽

And Control

The outcome of lymph node tuberculosis (LNTB) management with conventional anti-tubercular treatment alone is unsatisfactory. We conducted a randomised open-label controlled clinical trial in the Department of Respiratory Medicine in Government Institute of Dhaka, Bangladesh from April 2017 to March 2019. Compared with controls, 54 patients of LNTB received category 1 anti-tubercular treatment with additional prednisolone after randomisation. Complete resolution in 21/54 (75%) and 7 (26.9%), symptomatic improvement in 26 (92.9%) and 22 (84.6%) and complications in 11 (39.28%) and 16 (61.53%) were observed in the treatment and control group, respectively. Thus, we recommend the use of steroids in this setting.

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Comparison of Early Implant Failure Rates Between Subjects With and Without Orthodontic Treatment Before Dental Implantation

Journal of Oral Implantology ◽

10.1563/aaid-joi-d-17-00222 ◽

2019 ◽

Vol 45 (1) ◽

pp. 29-34

Author(s):

Li-ching Chang ◽

I-ming Tsai

Keyword(s):

Treatment Group ◽

Failure Rate ◽

Orthodontic Treatment ◽

Implant Failure ◽

Control Group ◽

Failure Rates ◽

Implant Surgery ◽

Dental Implantation ◽

And Control

The present study compared early dental implant failure rates between patients with and without orthodontic treatment before dental implantation. The data of adults who had undergone dental implantation between January 2007 and December 2016 were analyzed retrospectively. A total of 124 subjects with 255 implants were divided into a treatment group (46 subjects, 85 teeth) consisting of patients who had undergone implant surgery after orthodontic treatment and a control group of patients who had not undergone preimplant orthodontic treatment. Implants that failed before permanent crown fabrication were defined as failures. No significant differences in gender or age were found between the treatment group and controls. No significant differences were found in implant failure rates in either jaw between the treatment and control groups. However, the failure rate was still higher in the treatment group (14.81%) than in the control group (3.28%) for the maxilla. Results of this study demonstrate an increased implant failure rate only in the maxilla of patients who underwent orthodontic treatment before dental implantation, especially implant surgery combined with a sinus lift procedure. Further study with a larger sample size and longer follow-up period is necessary to confirm results of the present study and identify other confounding factors.

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AT-46 * VORINOSTAT AND BEVACIZUMAB FOR RECURRENT HIGH-GRADE GLIOMA: INTERIM ANALYSIS OF A PHASE II CLINICAL TRIAL

Neuro-Oncology ◽

10.1093/neuonc/nou237.45 ◽

2014 ◽

Vol 16 (suppl 5) ◽

pp. v18-v18

Author(s):

K. Peters ◽

D. Reardon ◽

D. Randazzo ◽

S. Dutton ◽

A. Edwards ◽

...

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Interim Analysis ◽

High Grade Glioma ◽

Phase Ii Clinical Trial ◽

High Grade

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Dropout Prevention for Youth with Disabilities: Efficacy of a Sustained School Engagement Procedure

Council review ◽

10.1177/001440299806500101 ◽

1998 ◽

Vol 65 (1) ◽

pp. 7-21 ◽

Cited By ~ 144

Author(s):

Mary F. Sinclair ◽

Sandra L. Christenson ◽

David L. Evelo ◽

Christine M. Hurley

Keyword(s):

Treatment Group ◽

Dropout Prevention ◽

School Engagement ◽

Behavioral Disabilities ◽

Control Group ◽

Youth With Disabilities ◽

Engagement Strategies ◽

Overall Performance ◽

And Control ◽

To Receive

The purpose of this study was to examine the efficacy of a sustained dropout prevention procedure that incorporated monitoring and school engagement strategies. Ninety-four students with learning and emotional/behavioral disabilities received interventions in Grades 7 and 8; half of the students (treatment group) continued to receive intervention through Grade 9. Results of this experimental study indicated that, for two of three measures, students in the treatment group were significantly more likely to be engaged in school than were control group students. The overall performance of both treatment and control students, however, points to the need for early and sustained support for students with learning and behavioral disabilities to attain academic and behavioral standards.

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