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

February 14, 2020 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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)

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • Rigshospitalet
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Institut Gustave Roussy
      • Venlo, Netherlands, 5912 BL
        • Viecuri Medical Centre Venlo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
Empiric strategy

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
Progression according to RECIST criteria or death of any cause.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: An expected average of 1 year
Response will be assessed using RECIST criteria
An expected average of 1 year
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
An expected average of 1 year
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
From the day of randomization to death or last date of follow-up, assessed up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2012

Primary Completion (Actual)

August 27, 2019

Study Completion (Actual)

August 27, 2019

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

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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