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

Primary Purpose

Neoplasms, Unknown Primary

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cancer Type ID test
No test Empiric strategy
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neoplasms, Unknown Primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rigshospitalet
  • Institut Gustave Roussy
  • Viecuri Medical Centre Venlo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

test-guided strategy

Empiric strategy

Arm Description

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

Gemcitabine/Cisplatin

Outcomes

Primary Outcome Measures

Progression free survival
Progression according to RECIST criteria or death of any cause.

Secondary Outcome Measures

Response rate
Response will be assessed using RECIST criteria
Tolerance (Toxicity grade III and IV, toxic death)
Toxicity will be assessed using NCI-CTC criteria version 4.0
Overall survival
Death of any cause

Full Information

First Posted
February 13, 2012
Last Updated
February 14, 2020
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT01540058
Brief Title
Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2012 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
August 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Unknown Primary

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test-guided strategy
Arm Type
Experimental
Arm Description
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
Arm Title
Empiric strategy
Arm Type
Active Comparator
Arm Description
Gemcitabine/Cisplatin
Intervention Type
Other
Intervention Name(s)
Cancer Type ID test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No test Empiric strategy
Intervention Description
Empiric strategy
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression according to RECIST criteria or death of any cause.
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
Secondary Outcome Measure Information:
Title
Response rate
Description
Response will be assessed using RECIST criteria
Time Frame
An expected average of 1 year
Title
Tolerance (Toxicity grade III and IV, toxic death)
Description
Toxicity will be assessed using NCI-CTC criteria version 4.0
Time Frame
An expected average of 1 year
Title
Overall survival
Description
Death of any cause
Time Frame
From the day of randomization to death or last date of follow-up, assessed up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Viecuri Medical Centre Venlo
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands

12. IPD Sharing Statement

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

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