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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2021-03-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer of Unknown Primary Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Tissue-of-origin test

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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site-specific therapy

standard treatments of sites of origin

Group Type EXPERIMENTAL

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

Intervention Type GENETIC

90-gene assay to predict the primary tumor site

standard empiric chemotherapy

Group Type ACTIVE_COMPARATOR

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

Intervention Type GENETIC

90-gene assay to predict the primary tumor site

Interventions

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

90-gene assay to predict the primary tumor site

Intervention Type GENETIC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No