Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP

NCT ID: NCT01540058

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-22
• Study Completion Date: 2019-08-27

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).

Conditions

Neoplasms, Unknown Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

test-guided strategy

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

Group Type: EXPERIMENTAL

Cancer Type ID test

Intervention Type: 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.

Empiric strategy

Gemcitabine/Cisplatin

Group Type: ACTIVE_COMPARATOR

No test Empiric strategy

Intervention Type: OTHER

Empiric strategy

Interventions

Cancer 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.

Intervention Type: OTHER

No test Empiric strategy

Empiric strategy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim FIZAZI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Rigshospitalet

Copenhagen, , Denmark

Institut Gustave Roussy

Villejuif, Val De Marne, France

Viecuri Medical Centre Venlo

Venlo, , Netherlands

Countries

Denmark; France; Netherlands

Other Identifiers

2011/1751

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A01202-39

Identifier Type: -

Identifier Source: org_study_id