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
| Registry | NCT03278600 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 182 (Actual) |
| Sponsor | Fudan University (Other) |
| Conditions | Cancer of Unknown Primary Site |
| Interventions | tissue-of-origin (ORIGIN-PanCA○R) profiling (Genetic) |
| Dates | start 2017-09-18, primary completion 2021-03-18, completion 2021-03-18, first posted 2017-09-11, last updated 2022-01-24 |
| Locations | 1 site in China |
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All trials for Cancer of Unknown Primary Site All trials of tissue-of-origin (ORIGIN-PanCA○R) profiling
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| site-specific therapy | Experimental | Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling | standard treatments of sites of origin |
| standard empiric chemotherapy | Active comparator | Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling | standard empiric chemotherapy |
Sex: All, ages: 18 Years to 75 Years
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 | City | Country | Status |
|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | China |