Cancer of Unknown Primary Site
Conditions
Brief summary
This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling in predicting primary site and directing therapy in patients with cancer of unknown primary.
Interventions
GENETICtissue-of-origin (ORIGIN-PanCA○R) profiling
90-gene assay to predict the primary tumor site
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Tissue-of-origin test
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation (medical history, physical examination, blood counts, chemistry profile, chest/abdomen computed tomography scans, positron emission tomography scan, and directed evaluation of all symptomatic areas). Patients were required to have one of the following histologies: adenocarcinoma, poorly differentiated neoplasms, poorly differentiated carcinoma, squamous carcinoma. Sufficient archived biopsy tissue from a surgical or core needle biopsy was required to perform the molecular profiling assay. Eastern Cooperative Oncology Group performance status of 0 to 2; no previous systemic therapy; measurable or evaluable disease (RECIST); and adequate organ function.
Exclusion criteria
* carcinoma limited to single site which can be potentially cured by surgery of radiotherapy.patients with symptomatic brain metastases, active clinical severe infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate | 2 months |
| overall survival | 12 months |
| Adverse Events | 2 months |
| biomarker analysis | 6 months |
Countries
China
Outcome results
None listed