Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
|ClinicalTrials.gov Identifier: NCT02021942|
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Inoperable Thymoma Local Recurrent Thymoma||Drug: SOM230 LAR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: SOM230 LAR
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Drug: SOM230 LAR
SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.
- Percent Change in Tumor Volume From Baseline to EOS [ Time Frame: at least 6 months ]To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.
- Tumor Resection Status [ Time Frame: at least 6 months ]
To evaluate the resection status based on the categories R0, R1 and ≥ R2 at EOS using CT or MRI imaging.
R0 resection means no residual tumor tissue (best status); R1 indicates microscopic residual tumor tissue and R2 indicates macroscopic residual tumor tissue (worst status).
- Assessment of Tumor Operability [ Time Frame: at least 6 months ]Assessment if patients reaching operability at the EOS.
- Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: at least 6 months ]
- Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status [ Time Frame: at least 6 months ]MG severity status is assessed by determining Titin-antibody status at Baseline and EOS.
- Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations [ Time Frame: at least 6 months ]MG severity status is assessed by measuring ACHR-antibody concentrations at Baseline and EOS.
- Health Related Quality of Life [ Time Frame: at least 6 months ]
Health related quality of life information was collected at Baseline and EOS using SF-36 questionnaire. Questionnaires had to be completed by the patients. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Patient reported answers were transformed into domain scores according to the guidelines provided by RAND/MOS. Statistical significance of the result was tested with a paired Wilcoxon rang sum test with a significance level of 0.05 considering only paired values (n=11) using PSPP Version 0.10.1.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021942
|Klinik und Poliklinik für Neurologie der Universität Regensburg|
|Regensburg, Bavaria, Germany, 93053|
|Principal Investigator:||Berthold Schalke, Prof. Dr.||Professor|