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ZETA : Prospective Observational Study (ZETA)

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ClinicalTrials.gov Identifier: NCT03730558
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Laurent Mineur, Institut Sainte Catherine

Brief Summary:

Primary objective

- Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR.

Secondary objective

  • Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate.
  • Evaluate the tolerance profile of aflibercept in combination with FOLFIRI.

    • Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•

Condition or disease Intervention/treatment
Metastatic Colon Cancer Combination Product: aflibercept + FOLFIRI

Detailed Description:

Inclusion criteria

  • All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
  • Age ≥18 years
  • Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin

Exclusion criteria :

  • Concurrent participation in a clinical trial
  • Patients who have previously received anti-VEGF agents and / or aflibercept in one trial.
  • Patients who received FOLFIRI in the first metastatic line.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Non-comparative Prospective Observational Cohort Study Describing the Safety and Efficacy of Aflibercept Administered in Combination With FOLFIRI After Failure Under Oxaliplatin + Anti-EGFR Therapy in the Treatment of Patients With Metastatic Colorectal Cancer in Practice Common
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 8, 2021
Estimated Study Completion Date : November 8, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Combination Product: aflibercept + FOLFIRI
    aflibercept + FOLFIRI


Primary Outcome Measures :
  1. Evaluate the efficacy of aflibercept in terms of progression-free survival (PFS) in association with FOLFIRI in patients treated in common practice for metastatic colorectal cancer (CCRM) after failure of oxaliplatin + anti-EGFR-based treatment [ Time Frame: 2 years ]
    progression-free survival (PFS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
Criteria

Inclusion criteria

  • All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
  • Age ≥18 years
  • Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin

Exclusion criteria :

  • Concurrent participation in a clinical trial
  • Patients who have previously received anti-VEGF agents and / or aflibercept in one trial.
  • Patients who received FOLFIRI in the first metastatic line

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730558


Contacts
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Contact: RANIA BOUSTANY, Dr 0490276161 r.boustany@isc84.org
Contact: CELESTE DAVID 0490276161 c.david@isc84.org

Locations
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France
Institut Sainte-Catherine Recruiting
Avignon, Vaucluse, France, 84000
Contact: Laurent Mineur, Doctor    04 90 27 62 68    l.mineur@isc84.org   
Principal Investigator: Laurent Mineur, Doctor         
Institut Sainte Catherine Recruiting
Avignon, France, 84000
Contact: RANIA BOUSTANY    0490276161    r.boustany@isc84.org   
Sponsors and Collaborators
Dr.Laurent Mineur

Additional Information:

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Responsible Party: Dr.Laurent Mineur, Principal investigator, Institut Sainte Catherine
ClinicalTrials.gov Identifier: NCT03730558     History of Changes
Other Study ID Numbers: ZETA 2017-A01724-49
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.Laurent Mineur, Institut Sainte Catherine:
metastatic
colon cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases