Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary

Fudan University

Status and phase

Completed

Phase 3

Conditions

Cancer of Unknown Primary Site

Treatments

Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling

Study type

Interventional

Funder types

Other

Identifiers

NCT03278600

Fudan CUP-001

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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