Metastatic Cancer
Conditions
Brief summary
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important. To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.
Detailed description
This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer. If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type. defined below: NEXT 1 trial is screening and feasibility -\> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)-\>NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)
Interventions
None listed
Sponsors
Samsung Medical Center
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pathologically confirmed metastatic malignancy * Written informed consent
Exclusion criteria
* patients who do not agree with biopsy * patients who do not have enough tissue for acquisition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | expected average of 3 years | To compare response rate (RR) (per RECIST 1.1) in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus RR in patient cohort with non-matched treatment based on molecular profiling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | expected average of 3 years | To compare PFS in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus PFS in patient cohort with non-matched treatment based on molecular profiling |
| feasibility | expected average of 3 years | To evaluate changes in the tumor's molecular profile on serial biopsies |
Countries
South Korea
Outcome results
None listed