Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP (GEFCAPI04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540058
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : February 17, 2020
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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).

Condition or disease Intervention/treatment Phase
Neoplasms, Unknown Primary Other: Cancer Type ID test Other: No test Empiric strategy Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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)
Actual Study Start Date : March 22, 2012
Actual Primary Completion Date : August 27, 2019
Actual Study Completion Date : August 27, 2019

Arm Intervention/treatment
Experimental: 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
Other: 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.

Active Comparator: Empiric strategy
Other: No test Empiric strategy
Empiric strategy

Primary Outcome Measures :
  1. Progression free survival [ 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 ]
    Progression according to RECIST criteria or death of any cause.

Secondary Outcome Measures :
  1. Response rate [ Time Frame: An expected average of 1 year ]
    Response will be assessed using RECIST criteria

  2. Tolerance (Toxicity grade III and IV, toxic death) [ Time Frame: An expected average of 1 year ]
    Toxicity will be assessed using NCI-CTC criteria version 4.0

  3. Overall survival [ Time Frame: From the day of randomization to death or last date of follow-up, assessed up to 18 months ]
    Death of any cause

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540058

Layout table for location information
Copenhagen, Denmark, 2100
Institut Gustave Roussy
Villejuif, Val De Marne, France, 94805
Viecuri Medical Centre Venlo
Venlo, Netherlands, 5912 BL
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Layout table for investigator information
Principal Investigator: Karim FIZAZI, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris

Layout table for additonal information
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT01540058    
Other Study ID Numbers: 2011-A01202-39
2011/1751 ( Other Identifier: CSET number )
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes