---
title: Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary
nct_id: NCT03278600
overall_status: COMPLETED
phase: PHASE3
sponsor: Fudan University
study_type: INTERVENTIONAL
primary_condition: Cancer of Unknown Primary Site
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03278600.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03278600"
ct_last_update_post_date: 2022-01-24
last_seen_at: "2026-05-12T06:32:17.184Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary

**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

**NCT ID:** [NCT03278600](https://clinicaltrials.gov/study/NCT03278600)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 182
- **Lead Sponsor:** Fudan University
- **Conditions:** Cancer of Unknown Primary Site
- **Start Date:** 2017-09-18
- **Completion Date:** 2021-03-18
- **CT.gov Last Update:** 2022-01-24

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **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
```

## Arms

- **site-specific therapy** (EXPERIMENTAL) — standard treatments of sites of origin
- **standard empiric chemotherapy** (ACTIVE_COMPARATOR) — standard empiric chemotherapy

## Interventions

- **tissue-of-origin (ORIGIN-PanCA○R) profiling** (GENETIC) — 90-gene assay to predict the primary tumor site

## Primary Outcomes

- **progression free survival** _(time frame: 6 months)_

## Secondary Outcomes

- **overall response rate** _(time frame: 2 months)_
- **overall survival** _(time frame: 12 months)_
- **Adverse Events** _(time frame: 2 months)_
- **biomarker analysis** _(time frame: 6 months)_

## Locations (1)

- Fudan University Cancer Hospital, Shanghai, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fudan university cancer hospital|shanghai||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03278600.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03278600*  
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