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Completed

NCT Number: NCT03278600

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

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.

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Key information

Conditions

Cancer of Unknown Primary Site Neoplasm Metastasis Neoplasms Neoplasms, Unknown Primary Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Cancer Hospital

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tissue-of-origin (ORIGIN-PanCA○R) profiling

Genetic

90-gene assay to predict the primary tumor site

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2017
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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