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

Phase 3

Completed

• Conditions: Cancer of Unknown Primary Site
• Interventions: Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling

• Registration Number: NCT03278600
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-09-18
• Status Verified: 2021-03
• Primary Completion: 2021-03-18
• Study Completion: 2021-03-18
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
site-specific therapy	tissue-of-origin (ORIGIN-PanCA○R) profiling	standard treatments of sites of origin
standard empiric chemotherapy	tissue-of-origin (ORIGIN-PanCA○R) profiling	standard empiric chemotherapy

Primary Outcome Measures

Name	Time	Method
progression free survival	6 months

Secondary Outcome Measures

Name	Time	Method
biomarker analysis	6 months
Adverse Events	2 months
overall response rate	2 months
overall survival	12 months

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China