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

Neoplasms, Unknown Primary Clinical Trial

— GEFCAPI04  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540058
• Other study ID #: 2011-A01202-39
• Secondary ID: 2011/1751
• Status: Completed
• Phase: Phase 3
• Start date: March 22, 2012
• Est. completion date: August 27, 2019

Study information

• Verified date: February 2020
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: August 27, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Unknown Primary

Intervention

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.
• No test Empiric strategy
Empiric strategy

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
France	Institut Gustave Roussy	Villejuif	Val De Marne
Netherlands	Viecuri Medical Centre Venlo	Venlo

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	National Cancer Institute, France

Countries where clinical trial is conducted

Denmark,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	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	Response rate	Response will be assessed using RECIST criteria	An expected average of 1 year
Secondary	Tolerance (Toxicity grade III and IV, toxic death)	Toxicity will be assessed using NCI-CTC criteria version 4.0	An expected average of 1 year
Secondary	Overall survival	Death of any cause	From the day of randomization to death or last date of follow-up, assessed up to 18 months