oncologische aandoening Carcinoma of unknown primay
Conditions
Interventions
Molecular analysis test
Sponsors
Viecuri Medisch Centrum voor Noord-Limburg
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients presenting with carcinoma of an unknown primary, confirmed by histo-pathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types: moderately or welldifferentiated 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 CUP, 12) Previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. Randomisation 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
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 women, and women who are breastfeeding, 8) Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective respons rate, Tolerance, Overall survival | — |
Countries
Netherlands
Outcome results
None listed