Neoplasms, Unknown Primary
Conditions
Brief summary
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).
Interventions
OTHERCancer Type ID test
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.
OTHERNo test Empiric strategy
Empiric strategy
Sponsors
National Cancer Institute, France
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients presenting with carcinoma of unknown primary, confirmed by histopathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types : moderately or well-differentiated adenocarcinoma, poorly-differentiated adenocarcinoma, undifferentiated carcinoma, squamous-cell carcinoma 2. Diagnostic work-up in keeping with Standard Options Recommandations des CAPI (Lesimple et al., 2003), 3. Age \> 18 years, 4. Performance Status 0, 1 or 2 according to ECOG 5. Good or poor prognosis CUP classified according to the GEFCAPI classification 6. CUP with at least one measurable lesion 7. Tumour sample available for molecular analysis 8. CUP not belonging to a subgroup requiring a specific treatment, 9. Satisfactory haematological, renal and hepatic function 10. Cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy, 11. No previous chemotherapy for a CUP 12. Previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. Randomization can be performed during this time frame. 13. All patients with reproductive potential must practice an effective method of birth control throughout the study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment 14. Information delivered to patient and informed consent form signed by the patient or legal representative.
Exclusion criteria
1. Patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial), 2. Patients with known HIV infection 3. Patients with symptomatic brain metastases, 4. Associated disease likely to prevent the patient from receiving the treatment, 5. Previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry, 6. Patients already included in another clinical trial with an experimental therapy, 7. Pregnant woman or woman who are breastfeeding, 8. Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 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 | Progression according to RECIST criteria or death of any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | An expected average of 1 year | Response will be assessed using RECIST criteria |
| Tolerance (Toxicity grade III and IV, toxic death) | An expected average of 1 year | Toxicity will be assessed using NCI-CTC criteria version 4.0 |
| Overall survival | From the day of randomization to death or last date of follow-up, assessed up to 18 months | Death of any cause |
Countries
Denmark, France, Netherlands
Outcome results
None listed