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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01540058
First received: February 13, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Neoplasms, Unknown Primary
Other: Cancer Type ID test
Other: No test Empiric strategy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Progression according to RECIST criteria or death of any cause.


Secondary Outcome Measures:
  • Response rate [ Time Frame: An expected average of 1 year ] [ Designated as safety issue: No ]
    Response will be assessed using RECIST criteria

  • Tolerance (Toxicity grade III and IV, toxic death) [ Time Frame: An expected average of 1 year ] [ Designated as safety issue: No ]
    Toxicity will be assessed using NCI-CTC criteria version 4.0

  • Overall survival [ Time Frame: From the day of randomization to death or last date of follow-up, assessed up to 18 months ] [ Designated as safety issue: No ]
    Death of any cause


Estimated Enrollment: 223
Study Start Date: March 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Gemcitabine/Cisplatin
Other: No test Empiric strategy
Empiric strategy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540058

Contacts
Contact: Karim FIZAZI, MD, PhD +33 1 42 11 43 17 karim.fizazi@igr.fr

Locations
Denmark
Rigshospitalet Active, not recruiting
Copenhagen, Denmark, 2100
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Karim FIZAZI, MD, PhD    +33 1 42 11 43 17    karim.fizazi@igr.fr   
Principal Investigator: Karim FIZAZI, MD, PhD         
Netherlands
Viecuri Medical Centre Venlo Active, not recruiting
Venlo, Netherlands, 5912 BL
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Investigators
Principal Investigator: Karim FIZAZI, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01540058     History of Changes
Other Study ID Numbers: 2011-A01202-39, 2011/1751
Study First Received: February 13, 2012
Last Updated: October 28, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014