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A Randomised Phase III Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With Carcinoma of an Unknown Primary (CUP)

Phase 3
18 Years
Open (Enrolling)
Neoplasms, Unknown Primary

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Trial Information

A Randomised Phase III Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With Carcinoma of an Unknown Primary (CUP)

Inclusion Criteria:

1. Patients presenting with carcinoma of unknown primary, confirmed by
histo-pathological 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, with
at least one measurable lesion

6. Tumour sample available for molecular analysis

7. CUP not belonging to a subgroup requiring a specific treatment,

8. Satisfactory haematological, renal and hepatic function

9. Cardiac, respiratory and neurological function compatible with the administration of
cisplatin chemotherapy,

10. No previous chemotherapy,

11. Previous radiotherapy completed at least 4 weeks earlier,

12. 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

13. 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Progression free survival

Outcome Description:

Progression according to RECIST criteria or death of any cause.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2012

Completion Date:

October 2016

Related Keywords:

  • Neoplasms, Unknown Primary
  • Neoplasms
  • Neoplasms, Unknown Primary