Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site

Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site - Phase II trial of treatment strategy using NGS for carcinoma of unknown primary

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016794

Enrollment

110

Registered

2015-03-13

Start date

2015-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated Carcinoma of Unknown Primary Site

Interventions

Treatment strategy using next generation sequencing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients must have biopsy-proven metastatic carcinoma (2)No previous treatment with any systemic therapy. (3)Patients must have biopsy material available to provide an adequate specimen for the gene profiling assay. (4)Age, over 20 years old. (5)An ECOG performance status 0, 1, or 2. (6)Laboratory values as follows: WBC 4000/micro L, Platelets 100,000/micro L, Serum AST/ALT <100 IU/L Serum bilirubin <1.5 mg/dl Serum creatinine < 1.5 mg/dL.

Exclusion criteria

Exclusion criteria: (1)Patients with the specific sub groups are not eligible: (2)Patients with uncontrolled brain metastases and all patients with meningeal metastases. (3)Women who are pregnant or lactating. drug within 28 days of starting treatment

Design outcomes

Primary

Measure	Time frame
One year overall survival rate	—

Secondary

Measure	Time frame
Overall survival, Progression free survival, response rate, safety, exploratory anarysis association between results of gene profiling and efficacy, Frequency of gene mutation/amplification	—

Countries

Japan

Contacts

Public ContactHidetoshi Hayashi

Kishiwada City Hospital Department of Medical Oncology

hidet31@gmail.com072-445-1000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026