CompletedNCT03278600Updated Jan 24, 2022

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

A Phase 3 interventional study of tissue-of-origin (ORIGIN-PanCA○R) profiling in Cancer of Unknown Primary Site, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-24.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 182
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Cancer of Unknown Primary Site

Browse trials for

Neoplasms, Unknown Primary 104

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts 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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 182 participants (actual)

Study arms

Experimental
site-specific therapy
standard treatments of sites of origin
Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling
Active comparator
standard empiric chemotherapy
standard empiric chemotherapy
Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling

Interventions

Genetictissue-of-origin (ORIGIN-PanCA○R) profiling
90-gene assay to predict the primary tumor site

What researchers measure

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

Study locations

1 site

Fudan University Cancer Hospital
Shanghai, 200032, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03278600
Lead sponsor: Fudan University
Responsible party: Xichun Hu (Professor, Fudan University) — Principal investigator
First posted: Sep 11, 2017
Start date: Sep 18, 2017
Primary completion: Mar 18, 2021
Completion: Mar 18, 2021
Last update: Jan 24, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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