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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/1751 | Other Identifier | CSET number |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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This is a european randomised, phase III, multi-centric study comparing a diagnostic and therapeutic strategy based on molecular analysis followed by suspected primary cancer tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown primary. The purpose of this trial is to determine whether or not a strategy based on molecular analysis is effective in improving the progression free survival rates of patients with carcinoma of unknown primary (CUP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test-guided strategy | Experimental | Treatment considered as the standard at the time of patient inclusion based on the primary cancer suspected by "the BioTheranostics Cancer Type ID test" molecular analysis |
|
| Empiric strategy | Active Comparator | Gemcitabine/Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Type ID test | Other | CancerTYPE ID is a real-time RT-PCR assay that measures and interprets the differential expression of 92 genes as a molecular correlate for tumor classification. The test classifies 28 main tumor types and 50 subtypes using an algorithm incorporating gene expression data from a reference database of 2,094 tumor specimens. CancerTYPE ID is used, in conjunction with other clinical and diagnostic procedures, to help identify tumor type and histological subtype. The performance characteristics and reproducibility of the test have been published previously (Erlander et al., 2011 ; Kerr et al., 2012). CancerTYPE ID is conducted on formalin-fixed paraffin-embedded (FFPE) tumor specimens at bioTheranostics' high complexity laboratory, which is certified by Clinical Laboratory Improvement Amendments (CLIA), accredited by the College of American Pathologists (CAP), and approved by the State of New York. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression according to RECIST criteria or death of any cause. | From date of randomization until the date of first progression or date of death from any cause, whichever came first, assessed up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response will be assessed using RECIST criteria | An expected average of 1 year |
| Tolerance (Toxicity grade III and IV, toxic death) | Toxicity will be assessed using NCI-CTC criteria version 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim FIZAZI, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Institut Gustave Roussy |
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| ID | Term |
|---|---|
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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| No test Empiric strategy | Other | Empiric strategy |
|
| An expected average of 1 year |
| Overall survival | Death of any cause | From the day of randomization to death or last date of follow-up, assessed up to 18 months |
| Villejuif |
| Val De Marne |
| 94805 |
| France |
| Viecuri Medical Centre Venlo | Venlo | 5912 BL | Netherlands |
| D013568 |
| Pathological Conditions, Signs and Symptoms |