Locally Advanced Carcinoma, Metastatic Cancer
Conditions
Keywords
Comprehensive Genomic Tumour Profiling, Targeted Therapy, Progression Free Survival, Next Generation Sequencing, Molecular Tumour Board, Tumour-specific Therapy
Brief summary
The aims of this study are * to evaluate the efficacy of comprehensive genomic tumour profiling (CGP) from liquid and/or tissue biopsy in patients with locally advanced and/or metastatic solid cancer. * to evaluate and describe the impact of treatment decisions based on CGP on individual progression free survival in patients with locally advanced and/or metastatic solid cancer * to evaluate and describe similarities and differences between the treatment suggestions based on CGP/IHC (immuno-histochemistry) of tissue biopsy and liquid biopsy. In patients with locally advanced and/or metastatic carcinoma the primary efficacy objective of the study is, to observe and describe the PFS (progression-free survival) of the matched treatment compared to the PFS of the most recent therapy.
Detailed description
The SOUND study will be exploring the treatment rates and outcomes of CGP-driven targeted treatment in patients with advanced or metastasized cancer. It will use a substantially larger gene-panel than previous studies in Austria. Departing from the routine clinical practice, study patients will have the opportunity to have CGP from liquid and/or tissue biopsy. The treatment decision will be discussed within a molecular tumour board consisting of experts in clinical oncology, human genetics and pathology. The treatment decision process will be supported and documented by a software. Data from the SOUND study will cover the whole analysis process, the reasons for the treatment decision, reasons for getting or not-getting a matched treatment as well as the outcome, treatment and hospitalisation costs. The SOUND study will give valuable insights into the clinical practice of CGP-driven therapy in Austria and describe the experience and the possible restrictions. Considering the differing conditions in Austria, the SOUND study will generate data that might be useful for best practice sharing with other countries in the future.
Interventions
DIAGNOSTIC_TESTNext Generation Sequencing
Molecular analysis of liquid biopsy.
GENETICBiomarker Monitoring
Biomarker Monitoring of study patients receiving matched therapy.
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Open, Prospective, Multicentre IVD (in vitro diagnostic device) Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initial diagnosis of histologically confirmed locally advanced and/or metastatic solid cancer * Radiologically confirmed progression under the most recent therapy * No further evidence-based drug treatment is established, or no satisfactory alternative treatments are available for the locally advanced and/or metastasized carcinoma * Further therapy is medically feasible * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Life expectancy of at least 12 weeks * Written informed consent and willingness to cooperate during the course of the study * Capability to understand the intention and the consequences of the study
Exclusion criteria
* Untreated CNS (central nervous system) metastases. Patients with treated CNS metastases are eligible if they are clinically stable with regard to neurologic function * Pregnant or breast feeding * Other malignomas, diagnosed \< 5a before inclusion (except localized squamous cell carcinomas of the skin, surgically curable melanomas of the skin, basal cell carcinomas of the skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3 | Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months | To observe and describe the PFS of the matched treatment compared to the PFS of the most recent therapy, PFS = number of calendar days from start treatment to progression of disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of potentially actionable targets | Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient | To evaluate the number of targets identified with NGS (next-generation sequencing) and IHC, that are potentially actionable with an approved drug on-label, off-label or an experimental drug per patient |
| Proportion of patients with potentially actionable targets | A maximum of 30 months after first patient first visit | To investigate the proportion of patients with targets actionable by an approved drug on-label, off-label or an experimental drug. |
| Calendar days from enrolment into the study to the date of death or last visit alive | Enrolment to death or last visit alive, that is on average about 8 months | To observe and describe overall survival (OS) |
| Proportion of patients with best overall response of either complete response (CR) or partial response (PR), based on their overall response | A maximum of 30 months after first patient first visit | To observe and describe objective response rate (ORR), Response will be evaluated by the investigator as defined by RECIST 1. or irRECIST |
| Proportion of patients with successful molecular profiling from liquid or tissue biopsy, in whom a matched therapy was recommended | A maximum of 30 months after first patient first visit | To investigate the proportion of patients with successful molecular profiling |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORPhilipp Jost, Univ.Prof.Dr.MD,
Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology
PRINCIPAL_INVESTIGATORArmin Gerger, Univ.Prof.,MD.
Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology
Outcome results
None listed