Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03730558
Other study ID # ZETA 2017-A01724-49
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2017
Est. completion date November 8, 2021

Study information

Verified date November 2018
Source Institut Sainte Catherine
Contact RANIA BOUSTANY, Dr
Phone 0490276161
Email r.boustany@isc84.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.•


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 8, 2021
Est. primary completion date November 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
aflibercept + FOLFIRI
aflibercept + FOLFIRI

Locations

Country Name City State
France Institut Sainte Catherine Avignon
France Institut Sainte-Catherine Avignon Vaucluse

Sponsors (1)

Lead Sponsor Collaborator
Dr.Laurent Mineur

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 progression-free survival (PFS) 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04186117 - Development of Clinical and Biological Database in Colorectal Cancer N/A
Completed NCT05468892 - Phase II Randomized Study Evaluating the Efficacy of Panitumumab (VEctibix ) and Trifluridine-Tipiracil (LOnsurf) in Pretreated RAS Wild Type Metastatic Colorectal Cancer Patients: the VELO Trial Phase 2
Recruiting NCT02291744 - A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients Phase 2
Active, not recruiting NCT00986661 - A Study to Assess PV-10 Chemoablation of Cancer of the Liver Phase 1
Completed NCT03176485 - Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors N/A
Recruiting NCT05983367 - A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer Phase 2
Recruiting NCT06180460 - CALM: Managing Distress in Malignant Brain Cancer N/A
Active, not recruiting NCT03251378 - A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer Phase 1
Recruiting NCT04737213 - SGM-101 in Colorectal Lung Metastases Phase 2
Recruiting NCT05714124 - Liver Embolization Approaches for Tumor Management
Recruiting NCT05396807 - REVERT - taRgeted thErapy for adVanced colorEctal canceR paTients N/A
Active, not recruiting NCT02724202 - Curcumin in Combination With 5FU for Colon Cancer Early Phase 1
Withdrawn NCT03764137 - Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer Phase 1/Phase 2
Recruiting NCT05848739 - A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors Phase 1
Not yet recruiting NCT06202183 - Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial N/A
Withdrawn NCT01936961 - Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors N/A
Not yet recruiting NCT06358677 - Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer Phase 2
Completed NCT03415126 - A Study of ASN007 in Patients With Advanced Solid Tumors Phase 1
Completed NCT02834052 - Pembrolizumab + Poly-ICLC in MRP Colon Cancer Phase 1/Phase 2
Not yet recruiting NCT06446557 - De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer Phase 3