CTNI-28. VOLUMETRIC AND DOSIMETRIC PATTERNS OF FAILURE ANALYSIS OF A PHASE II CLINICAL TRIAL OF 18F-DOPA-PET DIRECTED DOSE ESCALATED RADIOTHERAPY FOR GLIOBLASTOMA

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi65-vi65
Author(s):  
William Breen ◽  
S Keith Anderson ◽  
Deanna Pafundi ◽  
Timothy Kaufmann ◽  
Christopher Hunt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Low Dose ◽  
Recursive Partitioning ◽  
Secondary Analysis ◽  
Progression Free Survival ◽  
Phase Ii Clinical Trial ◽  
High Dose ◽  
Patterns Of Failure ◽  
Dose Volumes

Abstract While dose escalation of radiotherapy (DERT) has failed to improve overall survival (OS) or progression-free survival (PFS) for glioblastoma in previous studies, a recent phase II clinical trial utilizing 18F-DOPA-PET-directed DERT demonstrated improved PFS in MGMT-unmethylated patients and OS in MGMT-methylated patients compared to historical controls. This planned secondary analysis sought to determine 1) how 18F-DOPA-PET changes RT volumes beyond standard MRI-planning, 2) which patients benefit most and least from this protocol, 3) which are mostly likely to experience clinically significant radionecrosis after DERT, and 4) patterns of failure after DERT. For 69 evaluable patients, median MRI-defined, PET-defined, and combined low-dose gross tumor volumes (GTV51) were 54 cc (range 9-248), 23 cc (0.4-179), and 62 cc (10-260), respectively. Median MRI-defined, PET-defined, and combined high-dose GTVs (GTV76) were 32 cc (range 4-136), 6 cc (0.1-138), and 34 cc (4-162), respectively. 18F-DOPA-PET resulted in a median volumetric expansion of 13% (0-243%) and 5% (0-217%) from MRI-defined low-dose and high-dose GTV’s, respectively. Central failures ( >95% of recurrence tumor volume) occurred within the 76 Gy, 60 Gy, and 51 Gy isodose lines in 32 (46%), 60 (87%), and 64 (93%) patients, respectively. Recursive partitioning analysis stratified patients by OS and PFS. Patients with 18F-DOPA-PET-defined GTV76 > 7.8cc, MRI-defined GTV76 > 42.7cc, and MGMT promotor-unmethylated tumors had the shortest OS, while patients with smaller PET and MRI-defined tumors had the longest OS (median 10.4 vs. 64.6 months, p< 0.001). Similarly, PFS was worst in patients with 18F-DOPA-PET-defined GTV76 > 2.17 cc who had biopsy only (median PFS 3.2 months, p< 0.001). Patients with 18F-DOPA-PET-defined GTV51 > 50 cc had the highest risk of grade 3+ radionecrosis (p< 0.001). In conclusion, larger 18F-DOPA-PET and MRI-defined tumor volumes were associated with worse outcomes, and 18F-DOPA-PET-directed DERT appears to reduce risk of central recurrence in high-dose volumes.

scholarly journals Efficacy of low-dose rituximab for the treatment of mixed cryoglobulinemia vasculitis: Phase II clinical trial and systematic review

2015 ◽  
Vol 14 (10) ◽  
pp. 889-896 ◽  
Author(s):  
Marcella Visentini ◽  
Carmine Tinelli ◽  
Stefania Colantuono ◽  
Monica Monti ◽  
Serena Ludovisi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Phase Ii ◽  
Low Dose ◽  
Mixed Cryoglobulinemia ◽  
Phase Ii Clinical Trial

scholarly journals COVIDOSE: A Phase II Clinical Trial of Low‐Dose Tocilizumab in the Treatment of Noncritical COVID‐19 Pneumonia

2020 ◽  
Author(s):  
Garth W. Strohbehn ◽  
Brian L. Heiss ◽  
Sherin J. Rouhani ◽  
Jonathan A. Trujillo ◽  
Jovian Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Clinical Trial

scholarly journals A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis

CHEST Journal ◽  
2018 ◽  
Vol 153 (1) ◽  
pp. 94-104 ◽  
Author(s):  
Ivan O. Rosas ◽  
Hilary J. Goldberg ◽  
Harold R. Collard ◽  
Souheil El-Chemaly ◽  
Kevin Flaherty ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Carbon Monoxide ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Clinical Trial

Encouraging activity of bicalutamide and everolimus in castration-resistant prostate cancer (CRPC): Early results from a phase II clinical trial.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 157-157
Author(s):  
C. Pan ◽  
P. Ghosh ◽  
P. Lara ◽  
D. Robles ◽  
L. Beckett ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Progression ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Tumor Formation ◽  
Mtor Pathway ◽  
Phase Ii Clinical Trial ◽  
Castration Resistant Prostate Cancer ◽  
Early Results ◽  
Psa Response

157 Background: Multiple signaling pathways are involved in the development of CRPC. We previously showed that the mTOR pathway is activated in CRPC cell lines while inhibition of this pathway results in upregulation of androgen receptor (AR) signaling (Wang et al, Oncogene. 2008). Simultaneous blockade of the mTOR and AR pathways synergize in inducing PCa cell death and delaying tumor formation in mouse models. We hypothesize that simultaneous blockade of the AR and mTOR pathways in CRPC patients with bicalutamide and everolimus will result in improved efficacy compared to bicalutamide alone. Methods: A phase II clinical trial with a lead-in safety phase was designed to determine the efficacy and tolerability of the bicalutamide and everolimus combination in CRPC patients compared with bicalutamide alone. Patients must have histologically confirmed disease and demonstrated disease progression (either by PSA or radiographically) while on androgen deprivation therapy. At the lead-in phase, all patients receive both agents. At the phase II stage, patients are randomized to bicalutamide +/− everolimus. The primary endpoint is PSA response. The second endpoints include progression-free survival, time-to-treatment failure, overall survival and toxicity. Here, we report the results of the lead-in phase. Results: Eight patients were recruited at the lead-in phase. The bicalutamide/everolimus combination was well tolerated with no unexpected toxicities. Six of 8 patients have had PSA response after at least 8 weeks of therapy and the remaining two patients had stable PSA response. The median time to disease progression was 6.8 months. Nine patients have been recruited at the phase II stage so far. This clinical trial is being subcontracting to the other sites of the California Cancer Consortium. Tumor and blood specimens are being collected for molecular correlative studies of mTOR pathway markers. Conclusions: The rational combination of bicalutamide and everolimus appears to have promising anti-tumor activity and an acceptable toxicity profile. The randomized phase of the clinical trial is currently ongoing and will be reported. Supported by Novartis. [Table: see text]

scholarly journals The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-11
Author(s):  
Xuemei Liu ◽  
Juanjuan Fu ◽  
Tao Fan ◽  
Wei Liu ◽  
Hongli Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Study Protocol ◽  
Common Cold ◽  
Dose Group ◽  
Deficiency Syndrome ◽  
Phase Ii Clinical Trial ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

Background. Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. Methods/Design. This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson’s scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson’s scale and TCM symptom scale. Ethics and Trial Registration. This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).

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