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

Cancer of Unknown Primary Site Clinical Trial

Official title:

The Value of Tissue-of-origin (ORIGIN-PanCA○R) Profiling in Predicting Primary Site and Directing Therapy in Patients With Cancer of Unknown Primary: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278600
• Other study ID #: Fudan CUP-001
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2017
• Est. completion date: March 18, 2021

Study information

• Verified date: March 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Unknown Primary Site
• Neoplasms, Unknown Primary

Intervention

Genetic:
• tissue-of-origin (ORIGIN-PanCA?R) profiling
90-gene assay to predict the primary tumor site

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		6 months
Secondary	overall response rate		2 months
Secondary	overall survival		12 months
Secondary	Adverse Events		2 months
Secondary	biomarker analysis		6 months