Back to resultsTissue-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
About this trial
This is an interventional treatment trial for Cancer of Unknown Primary Site
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
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
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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