Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01540058
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01540058
Study Brief:
Protocol Section:
NCT01540058