- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01540058
Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP (GEFCAPI04)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Val De Marne
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Villejuif, Val De Marne, France, 94805
- Institut Gustave Roussy
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Venlo, Netherlands, 5912 BL
- Viecuri Medical Centre Venlo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Diagnostic work-up in keeping with Standard Options Recommandations des CAPI (Lesimple et al., 2003),
- Age > 18 years,
- Performance Status 0, 1 or 2 according to ECOG
- Good or poor prognosis CUP classified according to the GEFCAPI classification
- CUP with at least one measurable lesion
- Tumour sample available for molecular analysis
- CUP not belonging to a subgroup requiring a specific treatment,
- Satisfactory haematological, renal and hepatic function
- Cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy,
- No previous chemotherapy for a CUP
- 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.
- 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
- Information delivered to patient and informed consent form signed by the patient or legal representative.
Exclusion Criteria:
- Patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial),
- Patients with known HIV infection
- Patients with symptomatic brain metastases,
- Associated disease likely to prevent the patient from receiving the treatment,
- Previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry,
- Patients already included in another clinical trial with an experimental therapy,
- Pregnant woman or woman who are breastfeeding,
- Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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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
Gemcitabine/Cisplatin
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Empiric strategy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Progression according to RECIST criteria or death of any cause.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: An expected average of 1 year
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Response will be assessed using RECIST criteria
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An expected average of 1 year
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Tolerance (Toxicity grade III and IV, toxic death)
Time Frame: An expected average of 1 year
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Toxicity will be assessed using NCI-CTC criteria version 4.0
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An expected average of 1 year
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Overall survival
Time Frame: From the day of randomization to death or last date of follow-up, assessed up to 18 months
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Death of any cause
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From the day of randomization to death or last date of follow-up, assessed up to 18 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A01202-39
- 2011/1751 (Other Identifier: CSET number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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