A randomized controlled trial comparing modified gemcitabine plus oxaliplatin (mGEMOX) to gemcitabine plus cisplatin in the management of unresectable gall bladder cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4162-TPS4162
Author(s):  
Atul Sharma ◽  
Surendra Pal Chaudhary ◽  
N. K. Shukla ◽  
B. K. Mohanti ◽  
S. V. S. Deo ◽  
...  
Keyword(s):  
Gall Bladder ◽  
Supportive Care ◽  
Biliary Tract ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Progression Free Survival ◽  
Best Supportive Care ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Gemcitabine And Cisplatin

TPS4162 Background: In a recently conducted study we have shown that combination of gemcitabine and oxaliplatin is superior to 5 fluorouracil and leucoverine or best supportive care. (Sharma A, Dwary AD, Mohanti BK,et al. Best supportive care compared with chemotherapy for unresectable gall bladder cancer:A randomized controlled study. J Clin Oncol. 2010; 28: 4581-4586.) In another recent publication from UK, gemcitabine and cisplatin combination was found superior to gemcitabine alone in biliary tract cancers (J W Valle, HS Wasan, DD Palmer, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Eng J Med. 2010;362:1273-1281.).The current study is being planned to see whether the combination of gemcitabine and oxaliplatin is equivalent (equivalence study) to gemcitabine and cisplatin in these patients. Methods: Primary end point of the study is overall survival in subjects receiving mGEMOX or GemCis regimen. Secondary end points are: a) Comparison of progression free survival in 2 groups; b) Response rates in two groups; c) Identification of genes predictive of responses in a subset of patients; d) To evaluate role of PET CT in GBC patients predicting disease activity. Sample size was calculated taking median survival of 9.5 months in our previous study with mGEMOX and 11.7 months with GemCis. For this total of 216 patients are required (108 in each arm); to make for major protocol violation and lost to follow up additional 22 patients in each arm will be enrolled. Thus in total 260 patients (130) in each arm will be recruited. This will have alpha and beta values of 0.05 and 0.20 respectively. So far 103 patients have been enrolled and interim analysis is being planned. Treatment protocol: Cycles will be repeated every 3 weeks. Arm A- mGEMOX. Inj Oxaliplatin 80 mg/m22 hours infusion in Dextrose 5% Day 1 and 8. Inj Gemcitabine 900 mg/m2IV 30 minutes infusion day 1 and 8 maximum of 6 cycles. Arm B- GEMCIS. Inj Cisplatin 25 mg/m2PO Days 1 and 8. Inj Gemcitabine 1000 mg/m2IV 30 minutes infusion day1and 8 maximum of 8 cycles. Clinical trial information: CTRI/2010/091/001406.

Best Supportive Care Compared With Chemotherapy for Unresectable Gall Bladder Cancer: A Randomized Controlled Study

2010 ◽  
Vol 28 (30) ◽  
pp. 4581-4586 ◽  
Author(s):  
Atul Sharma ◽  
Amit Dutt Dwary ◽  
Bidhu Kalyan Mohanti ◽  
Surya V. Deo ◽  
Sujoy Pal ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Gall Bladder ◽  
Supportive Care ◽  
Controlled Trial ◽  
Randomized Study ◽  
Best Supportive Care ◽  
Gall Bladder Cancer ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Grade 3

Purpose We designed this study to evaluate efficacy of modified gemcitabine and oxaliplatin (mGEMOX) over best supportive care (BSC) or fluorouracil (FU) and folinic acid (FA) in unresectable gall bladder cancer (GBC). Patients and Methods Patients with unresectable GBC were enrolled for single center randomized study. Arm A, BSC; arm B, FU 425 mg/m2 and FA 20 mg/m2 intravenous (IV) bolus weekly for 30 weeks (FUFA); arm C, gemcitabine 900 mg/m2 and oxaliplatin 80 mg/m2 IV infusion on days 1 and 8 every 3 weeks for maximum of six cycles. Eighty-one patients were randomly assigned, arms A (n = 27), B (n = 28), and C (n = 26). Results Complete response plus partial response in the three groups was 0 (0%), four (14.3%), and eight (30.8%) respectively (P < .001). Two patients in the mGEMOX arm and one patient in the FUFA arm underwent curative resection after chemotherapy. One patient in the mGEMOX arm had complete pathologic response. Median overall survival (OS) was 4.5, 4.6, and 9.5 months for the BSC, FUFA, and mGEMOX arms (P = .039), respectively. Progression-free survival (PFS) was 2.8, 3.5, and 8.5 months for the three groups (P < .001). There was no difference in grade 3/4 toxicities in the chemotherapy arms except transaminitis, which was more prevalent in mGEMOX arm (P = .04). Two patients in the FUFA arm and 10 patients in the mGEMOX arm had grade 3 or 4 myelosuppression. Two patients in the mGEMOX group had neutropenic fever that resolved with antibiotics. Conclusion This randomized controlled trial confirmed the efficacy of chemotherapy (mGEMOX) compared with BSC and FUFA in improving OS and PFS in unresectable GBC.

scholarly journals Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Nicholas G. Nickols ◽  
Matthew B. Goetz ◽  
Christopher J. Graber ◽  
Debika Bhattacharya ◽  
Guy Soo Hoo ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Supportive Care ◽  
Controlled Trial ◽  
Best Supportive Care ◽  
Phase 2 ◽  
Lung Epithelium ◽  
Therapeutic Targeting ◽  
Randomized Controlled ◽  
Lhrh Antagonist ◽  
Cell Surface Protease

Abstract Background Therapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface protease. Pre-clinical and correlative data in humans suggest that anti-androgenic therapies can reduce the expression of TMPRSS2 on lung epithelium. Accordingly, we hypothesize that therapeutic targeting of androgen receptor signaling via degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, will suppress COVID-19 infection and ameliorate symptom severity. Methods This is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Enrolled patients must have documented infection with SARS-CoV-2 based on a positive reverse transcriptase polymerase chain reaction result performed on a nasopharyngeal swab and have a severity of illness of level 3–5 (hospitalized but not requiring invasive mechanical ventilation). Patients stratified by age, history of hypertension, and severity are centrally randomized 2:1 (degarelix: placebo). The composite primary endpoint is mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at 15 after randomization. Important secondary endpoints include time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a normal temperature, and the maximum severity of COVID-19 illness. Exploratory analyses aim to assess the association of cytokines, viral load, and various comorbidities with outcome. In addition, TMPRSS2 expression in target tissue and development of anti-viral antibodies will also be investigated. Discussion In this trial, we repurpose the FDA approved LHRH antagonist degarelix, commonly used for prostate cancer, to suppress TMPRSS2, a host cell surface protease required for SARS-CoV-2 cell entry. The objective is to determine if temporary androgen suppression with a single dose of degarelix improves the clinical outcomes of patients hospitalized due to COVID-19. Trial registration ClinicalTrials.gov NCT04397718. Registered on May 21, 2020

scholarly journals Hepatectomy versus TILA-TACE in the treatment of Resectable Hepatocellular Carcinoma: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Yangyang Feng ◽  
Yun Jin ◽  
Kai Jin ◽  
Yuanquan Yu ◽  
Donger Zhou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Effective Rate ◽  
Post Treatment ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Conventional Tace ◽  
Keywords Hepatocellular Carcinoma

Abstract Abstract Background: Hepatectomy and transcatheter arterial chemoembolization (TACE) are common treatments for hepatocellular carcinoma (HCC). Targeting intratumoral lactic acidosis TACE (TILA-TACE) is a new therapeutic approach developed by our team that has superior response rate and effective rate than conventional TACE (cTACE). In this randomized-controlled trial, we will compare the efficacy of hepatectomy and TILA-TACE in patients clinically diagnosed with HCC to provide reliable clinical data for the subsequent effective treatment of HCC patients. Methods: A total of 230 resectable HCC patients will be given hepatectomy or TILA-TACE using a parallel-controlled approach, and the efficacy of the treatments Page 4 of 24 will be compared. The primary endpoint is the post-treatment progression-free survival (PFS) of the patients, and the secondary endpoints are the post-treatment overall survival (OS), 1-year, 3-year and 5-year survival, and the quality of life of the patients at each corresponding stage. Discussion: The aim of this study is to compare the efficacy of hepatectomy and TILA-TACE in the treatment of resectable HCC. Trial registration: ClinicalTrials.gov,NCT03314532.Registered on 19 October 2017. Keywords: Hepatocellular carcinoma, Hepatectomy, TACE, TILA-TACE, Randomized-controlled study.

scholarly journals Hepatic resection versus TILA-TACE in the treatment of Resectable Hepatocellular Carcinoma: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Yangyang Feng ◽  
Yun Jin ◽  
Kai Jin ◽  
Yuanquan Yu ◽  
Donger Zhou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Randomized Controlled Trial ◽  
Hepatic Resection ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Effective Rate ◽  
Post Treatment ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Keywords Hepatocellular Carcinoma

Abstract Background: Hepatic resection and transcatheter arterial chemoembolization (TACE) are common treatments for hepatocellular carcinoma (HCC). Targeting intratumoral lactic acidosis TACE (TILA-TACE) is a new therapeutic approach developed by our team that has superior response rate and effective rate than conventional TACE (cTACE). In this randomized-controlled trial, we will compare the efficacy of hepatic resection and TILA-TACE in patients clinically diagnosed with HCC to provide reliable clinical data for the subsequent effective treatment of HCC patients. Methods: A total of 230 resectable HCC patients will be given hepatic resection or TILA-TACE using a parallel-controlled approach, and the efficacy of the treatments Page 4 of 24 will be compared. The primary endpoint is the post-treatment progression-free survival (PFS) of the patients, and the secondary endpoints are the post-treatment overall survival (OS), 1-year, 3-year and 5-year survival, and the quality of life of the patients at each corresponding stage. Discussion: The aim of this study is to compare the efficacy of hepatic resection and TILA-TACE in the treatment of resectable HCC. Trial registration: ClinicalTrials.gov,NCT03314532.Registered on 19 October 2017. Keywords: Hepatocellular carcinoma, Hepatic resection, TACE, TILA-TACE, Randomized-controlled study.

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

scholarly journals Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study

2021 ◽  
Author(s):  
Nien Xiang Tou ◽  
Shiou-Liang Wee ◽  
Wei Ting Seah ◽  
Daniella Hui Min Ng ◽  
Benedict Wei Jun Pang ◽  
...  
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Controlled Study ◽  
Power Training ◽  
Frail Older Adults ◽  
Frailty Status ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

AbstractTranslation of community-based functional training for older adults to reduce frailty is still lacking. We evaluated the effectiveness and implementation of a community-delivered group-based functional power training (FPT) program for frail older adults within their neighborhoods. A two-arm, multicenter assessor-blind stratified randomized controlled trial was conducted at four local senior activity centers in Singapore. Sixty-one community-dwelling older adults with low handgrip strength were randomized to intervention (IG) or control (CG) group. The IG underwent the FPT program (power and balance exercises using simple equipment) delivered by a community service provider. The 12-week program comprised 2 × 60 min sessions/week. CG continued usual activities at the centers. Functional performance, muscle strength, and frailty status were assessed at baseline and 3 months. Program implementation was evaluated using RE-AIM framework. The program was halted due to Coronavirus Disease 2019-related suspension of senior center activities. Results are reported from four centers, which completed the program. IG showed significantly greater improvement in the Short Physical Performance Battery test as compared to CG (p = 0.047). No effects were found for timed up and go test performance, muscle strength, and frailty status. The community program exhibited good reach, effectiveness, adoption, and implementation. Our study demonstrated that FPT was associated with greater improvement in physical function in pre-frail/frail participants as compared to exercise activities offered at local senior activity centers. It is a feasible intervention that can be successfully implemented for frail older adults in their neighborhoods. Trial registration ClinicalTrials.gov, NCT04438876. Registered 19 June 2020–retrospectively registered.

scholarly journals Current FDA-Approved Therapies for High-Grade Malignant Gliomas

Biomedicines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 324
Author(s):  
Jacob P. Fisher ◽  
David C. Adamson
Keyword(s):  
Controlled Trial ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
High Grade ◽  
Tumor Treatment ◽  
Free Survival ◽  
Randomized Controlled ◽  
Significant Survival ◽  
One Year

The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months. Before this SOC was established, glioblastoma (GBM) patients typically lived for less than one year after diagnosis, and no adjuvant chemotherapy had demonstrated significant survival benefits compared with radiation alone. In 2005, the Stupp et al. randomized controlled trial (RCT) on newly diagnosed GBM patients concluded that RT plus TMZ compared to RT alone significantly improved overall survival (OS) (14.6 vs. 12.1 months) and progression-free survival (PFS) at 6 months (PFS6) (53.9% vs. 36.4%). Outside of TMZ, there are four drugs and one device FDA-approved for the treatment of HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ), and tumor treatment fields (TTFields). These treatments are now mainly used to treat recurrent HGGs and symptoms. TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC. TTFields is the newest addition to this list of FDA-approved treatments, but has not been universally accepted yet as part of SOC.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

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