Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 895
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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)
Investigators
Jeeyun Lee
MD,PhD
Samsung Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Response rate
Time Frame: 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 Outcomes
- Progression Free Survival(expected average of 3 years)
- feasibility(expected average of 3 years)