ClinicalTrials.gg
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
01

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.

02

Conditions studied

  • Cancer of Unknown Primary Site
03

In context

Neoplasms, Unknown Primary

101 studies on the registry are indexed under Neoplasms, Unknown Primary; 19 are open to participants now.

This study's enrollment of 182 is above the median of 52 across 63 interventional studies indexed under Neoplasms, Unknown Primary.

Browse Neoplasms, Unknown Primary studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 tissue from a surgical or core needle biopsy was required to perform the molecular profiling assay. performance status of 0 to 2; no previous systemic therapy; measurable or evaluable disease (); 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 , active clinical severe infection
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

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

06

What researchers measure

Primary outcomes

  1. progression free survival

    Time frame: 6 months

Secondary outcomes

  1. overall response rate

    Time frame: 2 months

  2. overall survival

    Time frame: 12 months

  3. Adverse Events

    Time frame: 2 months

  4. biomarker analysis

    Time frame: 6 months

07

Study locations

1 site
  • Fudan University Cancer Hospital
    Shanghai, 200032, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Mar 2021, 42 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2017
First posted
Sep 11, 2017
StartActual
Sep 18, 2017
Primary completionActual
Mar 18, 2021
CompletionActual
Mar 18, 2021
Last update
Jan 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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