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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03278600
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Cancer of Unknown Primary Site Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : September 13, 2019
Estimated Study Completion Date : September 13, 2020

Arm Intervention/treatment
Experimental: site-specific therapy
standard treatments of sites of origin
Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling
90-gene assay to predict the primary tumor site

Active Comparator: standard empiric chemotherapy
standard empiric chemotherapy
Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling
90-gene assay to predict the primary tumor site

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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 or neuroendocrine tumors. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03278600

Contact: Xichun Xu, MD,PhD 86-21-64175590

Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD         
Sponsors and Collaborators
Fudan University

Responsible Party: Xichun Hu, Professor, Fudan University Identifier: NCT03278600     History of Changes
Other Study ID Numbers: Fudan CUP-001
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes