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

Primary Purpose

Cancer of Unknown Primary Site

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
tissue-of-origin (ORIGIN-PanCA○R) profiling
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Unknown Primary Site

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

site-specific therapy

standard empiric chemotherapy

Arm Description

standard treatments of sites of origin

standard empiric chemotherapy

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall response rate
overall survival
Adverse Events
biomarker analysis

Full Information

First Posted
September 8, 2017
Last Updated
January 21, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03278600
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Unknown Primary Site

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Tissue-of-origin test
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
site-specific therapy
Arm Type
Experimental
Arm Description
standard treatments of sites of origin
Arm Title
standard empiric chemotherapy
Arm Type
Active Comparator
Arm Description
standard empiric chemotherapy
Intervention Type
Genetic
Intervention Name(s)
tissue-of-origin (ORIGIN-PanCA○R) profiling
Intervention Description
90-gene assay to predict the primary tumor site
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall response rate
Time Frame
2 months
Title
overall survival
Time Frame
12 months
Title
Adverse Events
Time Frame
2 months
Title
biomarker analysis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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