Neoplasms, Unknown PrimaryPhase 3GEFCAPI04NCT01540058
Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP
A Phase 3 study testing Cancer Type ID test and No test Empiric strategy in people with Neoplasms, Unknown Primary, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Unknown Primary
- What is being tested?
- Cancer Type ID test and No test Empiric strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Mar 2012to 27 Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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)
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
- Being tested
- Cancer Type ID test, No test Empiric strategy
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Type ID testOther
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.
No test Empiric strategyOther
Empiric strategy
| Study group | Role | What they receive |
|---|---|---|
| test-guided strategy | Experimental | 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 Receives: Other: Cancer Type ID test |
| Empiric strategy | Active comparator | Gemcitabine/Cisplatin Receives: Other: No test Empiric strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression according to RECIST criteria or death of any cause.
Measured: 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 outcomes (3)
Response rate
Response will be assessed using RECIST criteria
Measured: An expected average of 1 year
Tolerance (Toxicity grade III and IV, toxic death)
Toxicity will be assessed using NCI-CTC criteria version 4.0
Measured: An expected average of 1 year
Overall survival
Death of any cause
Measured: From the day of randomization to death or last date of follow-up, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study start22 Mar 2012
- Primary completion27 Aug 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Unknown PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Karim FIZAZI, MD, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540058
- Sponsor's protocol ID
- 2011-A01202-39
- Other IDs
- 2011/1751
- Acronym
- GEFCAPI04
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2012
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01540058
- Acronym / sponsor ID
- GEFCAPI04 / 2011-A01202-39
- Conditions
- Neoplasms, Unknown Primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 22 Mar 2012 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test-guided strategy | Experimental | Other: Cancer Type ID testTreatment 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 |
| Empiric strategy | Active comparator | Other: No test Empiric strategyGemcitabine/Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer Type ID testCancerTYPE 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. | Other | test-guided strategy |
| No test Empiric strategyEmpiric strategy | Other | Empiric strategy |
Primary outcome
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.
3 secondary outcomes
Response rate
Time frame: An expected average of 1 year
Tolerance (Toxicity grade III and IV, toxic death)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim FIZAZI, MD, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cancer Type ID test and No test Empiric strategy in people with Neoplasms, Unknown Primary, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.